Quality Engineering Manager PDLM
In this role, you have the opportunity to
drive integration of PDLM into procedures, New Product Introduction, and significant changes to products, to ensure exceptional product quality, safety, design and reliability through the R&D/Product Development and Quality teams and into the product and through transfer to manufacturing and post market phase.
Key areas of responsibilities (KARS) for this role include:
- Work with Product Development, Manufacturing/NPI, Quality, Supplier Quality & Purchasing teams to develop and execute PQE activities to meet commercial milestones.
- Develop processes following the PDLM modules for advanced development, including analysis of current manufacturing capabilities to advise what changes will be required to manufacture new technologies in existing facilities.
- Support the analysis and evaluation of business situations and suggest alternative methods and procedures in solving problems and meeting quality requirements..
- Provide authoritative guidance on ISO, QSR and external standards requirements to the new product development teams, including review of standards being suggested and correct and maintain expectations where these would impact compliance with regulations.
- Train and mentor engineers and other project team members on best practices in quality engineering and regulatory compliance to external standards.
- Champion processes covering Quality Engineering and Quality Management to train, support, and encourage team members in the use of quality tools such as root cause analysis, risk analysis, FMECA, DOE, and statistical methods.
- Provide guidance about Six Sigma principles (Sampling, Acceptance, DOE, Statistical Process Control, Root Cause Analysis, FTA, control charts, capability analysis).
- Participate in designing and writing plans and protocols for testing of complex medical device products including software with R&D team.
- Develop and execute verification and validation plans and protocols associated with product/process quality according to FDA and ISO regulations and Verb SOPs.
- Review and draft process validation plans and protocols, and conduct validation testing of new or updated products and equipment, fixtures or tools as necessary.
- Assist in the development, improvement, and management of product assurance systems such as receiving quality assurance, in-process quality assurance, statistical process control, calibration / preventative maintenance, nonconforming materials, product lot release testing, and finished goods control. Identify and develop test methods and fixtures as needed.
- Participate in internal audits for quality systems, processes, and products to ensure compliance with regulations and internal specifications.
To succeed in this role, you should have the following skills and experience
- Minimum of Bachelor's degree in electrical or mechanical engineering
- Minimum of 5-years' experience in management of people
- Technical, Computer and Practical Skills
- Through applied knowledge of ISO 13485, ISO 14971, IEC 60601 standards and 21 CFR 820 and MDD regulations.
- Fluent in a wide variety of Quality tools such as 8D, 6S, 5 Why Analysis processes.
- Statistical and database software including Minitab and ReliaSoft applications.
- Working knowledge of statistics for R&D, quality, reliability and inspection.
- This position requires excellent verbal, written (English) and interpersonal communications skills with proven ability to translate technical information into effective procedures, plans, specifications and agreements.
- Ability to effectively present information in one-on-one and small group situations to supplier personnel, partners, consultants and employees at all levels of the organization.
- Ability to read, analyze, and interpret applicable scientific and technical journals, Standards and legal documents. Ability to respond to common inquiries from auditors, notified bodies, regulatory agencies, or members of the business community.
- Background in designing medical devices
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
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