Supplier Quality Engineer

Job TitleTechnical/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 The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skillsExperience 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