Job ID: 19534

Position Description:
AMETEK EMC has a great opportunity for a Quality Engineering Manager! Do you have experience in the medical device field? Are you passionate about people and developing a team of professionals to meet their full potential? This could be your next job opportunity!

The Quality Engineering Manager will provide Quality Engineering support and leadership to ensure the successful development of EMC products and materials. This individual will be expected to apply their knowledge of design control principles and quality engineering techniques to positively influence development efforts. In parallel, this position shall also ensure the products are developed and manufactured in accordance with TSE quality procedures, applicable industry standards, regulatory requirements and customer requirements. Review and evaluate scientific and technical data as it pertains to product and product testing and lead teams to identify and solve complex product problems. Individual will oversee Quality Engineering resources and efforts in multiple manufacturing facilities for the TSE business unit.

Duties and Responsibilities
1. Actively represent Quality Assurance function on product/process development teams.
2. Manage department resource allocation across multiple product lines, provide guidance and development opportunities for department employees.
3. Establish and install a vision for QA team, define objectives, manage team performance and coordination of assignments. Lead and develop members in the Quality department.
4. Provide Quality Engineering leadership by direct management and development of Quality Engineers, and indirect management and development of Engineering and audit resources.
5. Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, FDA, US 21 CFR 820 (QSR), ISO 13485, etc. and comply with applicable AMETEK Code of Ethics and Business conduct. Represent EMC as appropriate in FDA, notified body, internal, and other audits.
6. Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
7. Provide strategy and structure for New Product Quality with CAPA investigations and executions in the early stages of product development including, but not limited to customer/supplier interaction, product engineering, and prototype testing.
8. Report on the performance of Quality Systems to company management for review and ensure management reviews are held.
9. Provide Quality Leadership for the TSE business unity and provide reports on Product Life Cycle Management, CAPA and Risk Management, etc.
10. Lead the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.
11. Identifies and manages risk throughout the development process with the use of FMEA and/or other risk management tools. This includes leading Risk management efforts of the design process and working with design team and management team on managing product and process risks.
12. Develops master test plans that encompass design verification and validation activities.
13. Creation, evaluation, and validation of product and process test methods.
14. Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
15. Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
16. Analyzes and investigates returned product to determine the cause for return.
17. Contributes to design input requirements from experience with previously reported problems, company products, and/or other similar products.
18. Promotes continuous improvement in design control activities and use of quality tools with design team.
19. Lead and/or participate in the supplier selection process and specification reviews with suppliers to ensure that purchased items meet company specifications.
20. Specifies quality characteristics and inspection plans for components and subassemblies.
21. Evaluates and dispositions nonconforming materials and products used in development builds, to arrive at the most economical disposition, while meeting all quality system requirements.
22. Leads development and implementation of at least one family of product or process control procedures (e.g. Lean, Six Sigma, Risk Management, Process Control, etc.)
23. Leads scheduled and impromptu audits of the TSE quality management system as performed by registrars, regulators, and customers.

Position Requirements:
BS degree in engineering/sciences with at least 5 years of working experience in Quality Engineering and 2 years managing Engineers (preferably with Quality Engineering disciplines) in the medical device industry under FDA US 21 CFR 820 and ISO 13485 Medical Device - Quality Management Systems. Experience with risk management assessments and techniques, preferably in accordance with ISO 14971. Experience with product development and quality principles and practices. Experience leading and facilitating audits as well as managing teams (managing remote teams internationally is preferred but not required. Strong interpersonal, organizational and project management skills are required. Demonstrated ability to work productively with individuals at all levels inside and outside the organization, with an ability to influence key company and customer decision makers. Demonstrated proficiency with best in class data analysis tools (Minitab), statistical process control software (Infinity QS), customary PC office applications such as Word, Excel and PowerPoint required. Ability to travel, both Internationally and Domestically 30-40% of time.
Bonus qualifications but not required: Experience with contract manufacturing of cable assemblies, connectors, and injection molded components. Six Sigma certification. Supplier Quality Management experience.

We are an Equal Opportunity Employer and do not discriminate against
any employee or applicant for employment because of race, color, sex,
age, national origin, religion, sexual orientation, gender identity,
status as a veteran, and basis of disability or any other federal,
state or local protected class.

.