- Worked in Medical industry with minimum 8 years quality control and quality management system experience, minimum 4 years' experience of team leader, Medical or science and engineering related major is preferred.
- Proficiency and knowledgeable in the
- Able to communicate clearly and effectively in both verbal and written media.
- Good at problem-solving skill (e.g., PDCA,8D CAR, Lean Six Sigma tools).
- Skillful at excel data analysis, SQL, power BI, python, etc. data analysis tools is preferred.
- Fluent in English
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Principal Engineer of Quality Management System - Chicago, United States - Jabil Circuit, Inc.
Description
Prerequisites for Principal Engineer ofQMS:
QMS:
ISO 13485 and relative statutory and legulatory requirements are the basic, if candidate also has proficiency and is knowledgeable in IATF 16949, VDA 6.3, etc., it will be priority.
QMS:
1.1 QMS Set Up and Internal Audit
1.1 Lead and coordinate the new QMS standard set up in the company, e.g. ISO 13485 or other relative requirements.
1.2 Conduct risk assessment for workcell & QMS Process and convert into QMS annual internal audit plan, e.g. ISO 13485, ISO 9001, etc.
1.3 Review QMS annual internal audit plan in JCAS system.
1.4 Lead team to conduct specific ISO 13485 QMS half-yearly/ annual internal audit.
1.5 Supervise team to follow up QMS internal audit lesson learnt and work out systematic improvement action plan.
1.6 Conduct special audit, such as Change Management, CSR audit etc.
1.7 Conduct weekly/ semi-yearly plant level JOS audit.
2 QMS External Audit
2.1 Lead team to prepare and coordinate ISO 13485 and the other external audit, e.g. FDA, GMP, etc.
2.2 Take part in the other QMS external audit, such as ISO 9001, IATF 16949, etc.
2.3 Lead team to follow up external audit findings, and take part in other QMS standards external audit findings improvement activities.
3 Customer Audit3.1 Support new/existing customer audit.
3.2 Assist workcell to get preparation for typical customer audit.
4 Management Review
4.1 Lead team to conduct ISO 13485 Management Review.
5 QMS Document Review
5.1 Conduct global QMS document gap analysis review and train if needed, especially for Healthcare/Medical sector related document
5.2 Follow up global document gap analysis status.
5.3 General document collaboration review
5.4 Simplify, Optimize and Standardize the process and revise QMS related document.
6 Training & Development
6.1 Conduct training about ISO 13485, relative statutory and legulatory requirements, or other QMS standard, for newcomer or per business required.
6.2 Provide support to other departments on systems related questions and problems.7 Digital Solution
7.1 Work out digital solution for function or workcell processes and tasks to improve the process efficiency and quality.
8 Advanced quality involvement for new workcell.
8.1 Arrange training about ISO 13485, FDA, ISO 9001, etc. QMS related procedures and customer requirement for team members from new workcell.
8.2Conduct CSR gap analysis and follow up actions for gap during audit.
8.3Conduct specific audit to new workcells based on risk assessment.
9 Customer Specific Requirements (CSR)
9.1 Training of CSR to workcell members, espcially for Medical workcell
9.2 Support to establish CSR checklist for wokcell.
9.3 Conduct internal CSR audit for workcell.
10 Follow QA SME Manager's other job assignment.
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