Technical/Functional Skills :
• Medical Device Domain Experience
• Good understanding of ISO 13485, ISO19471, 21CFR PART 11 & 21CFR PART 820
• Knowledge of Gage R&R, QFD, MSA, AAA, Hypothesis Testing, RISK Mitigation, P-FMEA, Control Chart-Variable & Attributes
• Knowledge of Validation and verification activities (IQ/OQ/PQ)
Roles & Responsibilities:
• Ensures that suppliers deliver quality parts, materials, and services
• Qualifies suppliers according to company standards (PPAP- Production Part Approval Process) and may administer a Certified Supplier Program in receiving inspection
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation
• Works with supplier to obtain each deliverable according to the PPAP procedure and evaluate adequacy to the requirements
• Must have experience with PFMEA, Process controls, MSA, Supplier Validation (IQ/OQ/PQ), Process Capability
• Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results
• May act as a mentor to colleagues or may direct the work of other lower level professionals
• Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
• May act as a mentor to colleagues or may direct the work of other lower level professionals.
• The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills.
Experience Required:
• Bachelor's Degree in engineering or Technical Field or equivalent combination of education and work experience
• Min 3 years of related experience
• Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO19471, 21CFR PART 11 & 21CFR PART 820.
• Good communication and interpersonal skills.
• Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• ASQ CQE or other certifications preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.
