Vacancy expired!
- 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)
- 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.
- 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.
- 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.
Vacancy expired!