Supplier Quality Engineer - Job Ref No HST267
IF YOU ARE LOOKING FOR A PASSIONATE AND DEDICATED TECHNOLOGY COMPANY WHERE YOU CAN BUILD A CAREER, THEN HEARTSINE MAY BE THE PLACE FOR YOU. AT HEARTSINE, WE ARE CUSTOMER-DRIVEN AND COMMITTED TO EXCELLENCE IN DEFIBRILLATION TECHNOLOGY. WE ARE DEDICATED TO REACHING OUR GOALS UNDER THE GUIDANCE OF HIGH ETHICS, THE DEVELOPMENT OF INNOVATIVE TECHNOLOGY, AND THROUGH THE HIRING OF TALENTED, MOTIVATED INDIVIDUALS.
HEARTSINE Technologies Limited, a subsidiary of Stryker Inc, one of the largest medical companies in the world, seeks to invite applications for the following permanent post:
Supplier Quality Engineer - Job Ref No HST267 An excellent opportunity has arisen within the Quality department of HeartSine Technologies Limited. As Supplier Quality Engineer, you will manage all aspects of tier one and sub-tier supplier quality activities for assigned
suppliers/commodities
suppliers/commodities.
and
drive
quality
and
process
improvement
at
assigned
You will be responsible for assessing, monitoring, and ensuring the continued
adequacy and effectiveness of the quality system for the assigned supplier base. You will also support supplier selection, supplier process validation/controls and general supplier development. Reviewing and approving inspection sampling plans for selection parts will also be a key part of your role.
In addition, you will manage all aspects of the Internal QMS auditing program. You will ensure that all internal audits are carried out to the approved schedule/plan whilst ensuring initiatives, all action plans and corrective actions are completed within agreed timelines. You will also participate in ongoing improvements within department.
Responsibilities
Work closely with tier one suppliers to sustain and improve component quality.
Ensure the proper validation of supplier processes and test methods and the product/process change management process.
Participate in approval of Goods Inward Work Instructions to ensure they complement the inspection activities carried out by the supplier.
Manage first article inspection process along with measurement system analysis (MSA), component qualification, and process validation including HeartSine manufacturing process verification if required.
Own and maintain supplier part control plans (SPCPs).
Approve supplier manufacturing/test/inspection plans and procedures; perform periodic supplier audits in compliance with approved schedule/plan and risk assessments as well as support new supplier development and commodity team strategies.
Impose supplier product/process change management process.
Ensure accurate and complete preparation of supplier quality engineering documents as required, including but not limited to component qualification/process validation plans, supplier audits/approvals, incoming inspection planning, and other miscellaneous quality documentation and records.
Participate in design reviews with the development teams.
Apply sound quality principles such as six sigma, lean, and statistical process control, to drive internal and supplier quality and process improvement.
Establish component level ongoing reliability testing (ORT) at factory and drive quality improvement if required.
Drive failure analysis and corrective actions/supplier corrective action requests (SCAR) within assigned suppliers/commodities.
Support MRB/non-conforming material processes as well as approved vendor list (AVL) sign off procedures.
Ensure that all internal QMS audits are carried out in compliance with approved schedule/plan.
Ensure that all action plans from all audits (internal and supplier) are completed within approved timelines.
Ensure that all corrective actions for non-conformances/observations from all audit are fully implemented and, where appropriate, verified as effective.
Domestic and international travel (20-40%).
Who we're looking for:
Qualifications & Experience: Essential
Bachelor's degree in an engineering or technical science, or equivalent combination of education and directly relevant experience.
3 years’ directly relevant experience, with a minimum of 2 years of recent prior experience in a high-tech or FDA/cGMP environment.
Desirable
5+ years’ of directly relevant experience.
Advanced degree (MS and/or MBA).
Prior experience working with electrical, mechanical, and/or electro-mechanical commodities.
ASQ certified quality auditor (CQA) and/or green belt certification.
General statistical quality tools knowledge with process capability; demonstrated ability to apply six sigma and statistical quality control methodologies.
Knowledge of specification development, industry standards, geometric dimensioning and tolerancing (GD&T), etc.
Lead ISO Auditor certification.
Demonstrated ability to drive and deliver innovative, effective and timely solutions.
Responsible To: Quality Manager
Location: This job will be based at HeartSine’s Belfast facility, Heron Avenue, Belfast.
Our Offer: An attractive package is on offer to the successful candidate, having the opportunity to participate in the manufacture of a market leading life-saving product, whilst being part of a rapidly growing dynamic company. Salary will be based on experience with additional company benefits.
To Apply Please send a cover letter and CV to [email protected] by Friday 24th February 2017. Applications received after the closing date will not be accepted. HeartSine Technologies Limited is an equal opportunity employer and applications are welcomed regardless of race, ethnic origin, gender, sexual orientation, age, political or religious beliefs, disability or marital status.
Job Description Job Title
Supplier Quality Engineer
Responsible To
Quality Manager
Hours of Work
Refer to Terms
Responsible For
None
Department/Location Quality Job Summary As a supplier of life-saving medical devices to customers all over the world, HeartSine Technologies must implement stringent controls for it’s critical suppliers. The job involves developing sound relationships with all critical suppliers in order to deliver consistent compliant goods and materials to the Belfast site. The job will involve visiting the critical suppliers to carry out regular audits and also to review systems which ensure consistency of supply. The job will also involve some involvement with HeartSine’s internal quality management system auditing. Main Duties & Responsibilities 1
Work closely with tier one suppliers to sustain and improve component quality. Ensure the proper validation of supplier processes and test methods and the product/process change management process. Participate in approval of Goods Inward Work Instructions to ensure they complement the inspection activities carried out by the supplier. Manage first article inspection process along with measurement system analysis (MSA), component qualification, and process validation including HeartSine manufacturing process verification if required.
2 3 4 5
Own and maintain supplier part control plans (SPCPs).
6
Approve supplier manufacturing/test/inspection plans and procedures; perform periodic supplier audits in compliance with approved schedule/plan and risk assessments as well as support new supplier development and commodity team strategies.
7
Impose supplier product/process change management process.
8
Ensure accurate and complete preparation of supplier quality engineering documents as required, including but not limited to component qualification/process validation plans, supplier audits/approvals, incoming inspection planning, and other miscellaneous quality documentation and records.
9
Participate in design reviews with the development teams.
10
Apply sound quality principles such as six sigma, lean, and statistical process control, to drive internal and supplier quality and process improvement.
11
Establish component level ongoing reliability testing (ORT) at factory and drive quality improvement if required.
12
Drive failure analysis and corrective actions/supplier corrective action requests (SCAR) within assigned suppliers/commodities.
13
Support MRB/non-conforming material processes as well as approved vendor list (AVL) sign off procedures.
14
Ensure that all internal QMS audits are carried out in compliance with approved schedule/plan.
15
Ensure that all action plans from all audits (internal and supplier) are completed within approved timelines.
16 and
Ensure that all corrective actions for non-conformances/observations from all audit are fully implemented and, where appropriate, verified as effective. Any other duties deemed necessary by the Quality Manager/EMEA Director, Quality & Regulatory or General Manager/Site Leader
Note: This description is not intended to establish a total definition of the job, and may include all or a selection of the above duties.
Person Specification Job Title
Supplier Quality Engineer
Job Reference Number:
HST267
Date
13/02/17
Department:
Quality
Essential (Those qualities which are essential to perform the job)
Desirable (Those qualities which allow the job to be performed to the optimum level)
Bachelor's degree in an engineering or technical science, or
Advanced degree (MS and/or MBA).
Qualities
Education/Qualifications e.g. academic or professional qualifications
equivalent combination of education and directly relevant experience.
Work Experience Previous experience required to do the job
3 years’ directly relevant experience, with a minimum of 2 years of recent prior experience in a high-tech or FDA/cGMP environment.
5+ years’ of directly relevant experience. Prior experience working with electrical, mechanical, and/or electro-mechanical commodities. General statistical quality tools knowledge with process capability
Knowledge of specification development, industry standards, geometric dimensioning and tolerancing (GD&T), etc. Lead ISO Auditor certification.
Skills/Abilities e.g. analytical skills, computer skills
Excellent verbal and written communication skills
Demonstrated ability to apply six sigma and statistical quality control methodologies.
Working knowledge of Microsoft Office ASQ certified quality auditor (CQA) and/or green belt certification.
Personal Details e.g. leadership, flexibility, team working
Conscientious individual demonstrating attention to detail along with high levels of ownership and commitment A good team player capable of delivering results to deadlines
Other Circumstances Special conditions that apply to the job, e.g. need to travel, work away from home etc.
Domestic and international travel 20% - 40%
Demonstrated ability to drive and deliver innovative, effective and timely solutions.
HEARTSINE Technologies Limited, a subsidiary of Stryker Inc, one of the largest medical companies in the world, seeks to invite applications for the following permanent post:
Supplier Quality Engineer - Job Ref No HST267 An excellent opportunity has arisen within the Quality department of HeartSine Technologies Limited. As Supplier Quality Engineer, you will manage all aspects of tier one and sub-tier supplier quality activities for assigned
suppliers/commodities
suppliers/commodities.
and
drive
quality
and
process
improvement
at
assigned
You will be responsible for assessing, monitoring, and ensuring the continued
adequacy and effectiveness of the quality system for the assigned supplier base. You will also support supplier selection, supplier process validation/controls and general supplier development. Reviewing and approving inspection sampling plans for selection parts will also be a key part of your role.
In addition, you will manage all aspects of the Internal QMS auditing program. You will ensure that all internal audits are carried out to the approved schedule/plan whilst ensuring initiatives, all action plans and corrective actions are completed within agreed timelines. You will also participate in ongoing improvements within department.
Responsibilities
Work closely with tier one suppliers to sustain and improve component quality.
Ensure the proper validation of supplier processes and test methods and the product/process change management process.
Participate in approval of Goods Inward Work Instructions to ensure they complement the inspection activities carried out by the supplier.
Manage first article inspection process along with measurement system analysis (MSA), component qualification, and process validation including HeartSine manufacturing process verification if required.
Own and maintain supplier part control plans (SPCPs).
Approve supplier manufacturing/test/inspection plans and procedures; perform periodic supplier audits in compliance with approved schedule/plan and risk assessments as well as support new supplier development and commodity team strategies.
Impose supplier product/process change management process.
Ensure accurate and complete preparation of supplier quality engineering documents as required, including but not limited to component qualification/process validation plans, supplier audits/approvals, incoming inspection planning, and other miscellaneous quality documentation and records.
Participate in design reviews with the development teams.
Apply sound quality principles such as six sigma, lean, and statistical process control, to drive internal and supplier quality and process improvement.
Establish component level ongoing reliability testing (ORT) at factory and drive quality improvement if required.
Drive failure analysis and corrective actions/supplier corrective action requests (SCAR) within assigned suppliers/commodities.
Support MRB/non-conforming material processes as well as approved vendor list (AVL) sign off procedures.
Ensure that all internal QMS audits are carried out in compliance with approved schedule/plan.
Ensure that all action plans from all audits (internal and supplier) are completed within approved timelines.
Ensure that all corrective actions for non-conformances/observations from all audit are fully implemented and, where appropriate, verified as effective.
Domestic and international travel (20-40%).
Who we're looking for:
Qualifications & Experience: Essential
Bachelor's degree in an engineering or technical science, or equivalent combination of education and directly relevant experience.
3 years’ directly relevant experience, with a minimum of 2 years of recent prior experience in a high-tech or FDA/cGMP environment.
Desirable
5+ years’ of directly relevant experience.
Advanced degree (MS and/or MBA).
Prior experience working with electrical, mechanical, and/or electro-mechanical commodities.
ASQ certified quality auditor (CQA) and/or green belt certification.
General statistical quality tools knowledge with process capability; demonstrated ability to apply six sigma and statistical quality control methodologies.
Knowledge of specification development, industry standards, geometric dimensioning and tolerancing (GD&T), etc.
Lead ISO Auditor certification.
Demonstrated ability to drive and deliver innovative, effective and timely solutions.
Responsible To: Quality Manager
Location: This job will be based at HeartSine’s Belfast facility, Heron Avenue, Belfast.
Our Offer: An attractive package is on offer to the successful candidate, having the opportunity to participate in the manufacture of a market leading life-saving product, whilst being part of a rapidly growing dynamic company. Salary will be based on experience with additional company benefits.
To Apply Please send a cover letter and CV to [email protected] by Friday 24th February 2017. Applications received after the closing date will not be accepted. HeartSine Technologies Limited is an equal opportunity employer and applications are welcomed regardless of race, ethnic origin, gender, sexual orientation, age, political or religious beliefs, disability or marital status.
Job Description Job Title
Supplier Quality Engineer
Responsible To
Quality Manager
Hours of Work
Refer to Terms
Responsible For
None
Department/Location Quality Job Summary As a supplier of life-saving medical devices to customers all over the world, HeartSine Technologies must implement stringent controls for it’s critical suppliers. The job involves developing sound relationships with all critical suppliers in order to deliver consistent compliant goods and materials to the Belfast site. The job will involve visiting the critical suppliers to carry out regular audits and also to review systems which ensure consistency of supply. The job will also involve some involvement with HeartSine’s internal quality management system auditing. Main Duties & Responsibilities 1
Work closely with tier one suppliers to sustain and improve component quality. Ensure the proper validation of supplier processes and test methods and the product/process change management process. Participate in approval of Goods Inward Work Instructions to ensure they complement the inspection activities carried out by the supplier. Manage first article inspection process along with measurement system analysis (MSA), component qualification, and process validation including HeartSine manufacturing process verification if required.
2 3 4 5
Own and maintain supplier part control plans (SPCPs).
6
Approve supplier manufacturing/test/inspection plans and procedures; perform periodic supplier audits in compliance with approved schedule/plan and risk assessments as well as support new supplier development and commodity team strategies.
7
Impose supplier product/process change management process.
8
Ensure accurate and complete preparation of supplier quality engineering documents as required, including but not limited to component qualification/process validation plans, supplier audits/approvals, incoming inspection planning, and other miscellaneous quality documentation and records.
9
Participate in design reviews with the development teams.
10
Apply sound quality principles such as six sigma, lean, and statistical process control, to drive internal and supplier quality and process improvement.
11
Establish component level ongoing reliability testing (ORT) at factory and drive quality improvement if required.
12
Drive failure analysis and corrective actions/supplier corrective action requests (SCAR) within assigned suppliers/commodities.
13
Support MRB/non-conforming material processes as well as approved vendor list (AVL) sign off procedures.
14
Ensure that all internal QMS audits are carried out in compliance with approved schedule/plan.
15
Ensure that all action plans from all audits (internal and supplier) are completed within approved timelines.
16 and
Ensure that all corrective actions for non-conformances/observations from all audit are fully implemented and, where appropriate, verified as effective. Any other duties deemed necessary by the Quality Manager/EMEA Director, Quality & Regulatory or General Manager/Site Leader
Note: This description is not intended to establish a total definition of the job, and may include all or a selection of the above duties.
Person Specification Job Title
Supplier Quality Engineer
Job Reference Number:
HST267
Date
13/02/17
Department:
Quality
Essential (Those qualities which are essential to perform the job)
Desirable (Those qualities which allow the job to be performed to the optimum level)
Bachelor's degree in an engineering or technical science, or
Advanced degree (MS and/or MBA).
Qualities
Education/Qualifications e.g. academic or professional qualifications
equivalent combination of education and directly relevant experience.
Work Experience Previous experience required to do the job
3 years’ directly relevant experience, with a minimum of 2 years of recent prior experience in a high-tech or FDA/cGMP environment.
5+ years’ of directly relevant experience. Prior experience working with electrical, mechanical, and/or electro-mechanical commodities. General statistical quality tools knowledge with process capability
Knowledge of specification development, industry standards, geometric dimensioning and tolerancing (GD&T), etc. Lead ISO Auditor certification.
Skills/Abilities e.g. analytical skills, computer skills
Excellent verbal and written communication skills
Demonstrated ability to apply six sigma and statistical quality control methodologies.
Working knowledge of Microsoft Office ASQ certified quality auditor (CQA) and/or green belt certification.
Personal Details e.g. leadership, flexibility, team working
Conscientious individual demonstrating attention to detail along with high levels of ownership and commitment A good team player capable of delivering results to deadlines
Other Circumstances Special conditions that apply to the job, e.g. need to travel, work away from home etc.
Domestic and international travel 20% - 40%
Demonstrated ability to drive and deliver innovative, effective and timely solutions.
