Technical / Functional Skills :
- Medical Device Domain Experience
- Good understanding of ISO , ISO, CFR PART & CFR PART
- 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 years of related experience
- Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools / methodologies.
- Detailed knowledge of FDA, GMP, ISO , and ISO, CFR PART & CFR PART .
- 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 (, Six Sigma and Lean Manufacturing).
- ASQ CQE or other certifications preferred.
- Experience working in a broader enterprise / cross-division business unit model preferred.
Supplier Quality Engineer
Join a forward-thinking team in the medical device industry, where you'll drive product quality and supplier collaboration. Take ownership of supplier relationships and quality initiatives. Partner with suppliers to resolve quality issues with materials and components. Travel (up to 25%) to enga...
Supplier Quality Engineer
Join a forward-thinking team in the medical device industry, where you'll drive product quality and supplier collaboration. Take ownership of supplier relationships and quality initiatives. Partner with suppliers to resolve quality issues with materials and components. Travel (up to 25%) to engage w...
Supplier Quality Engineer
Join a forward-thinking team in the medical device industry, where you'll drive product quality and supplier collaboration. Take ownership of supplier relationships and quality initiatives. Partner with suppliers to resolve quality issues with materials and components. Travel (up to 25%) to engage w...
Supplier Quality Engineer
Join a forward-thinking team in the medical device industry, where you'll drive product quality and supplier collaboration. Take ownership of supplier relationships and quality initiatives. Partner with suppliers to resolve quality issues with materials and components. Travel (up to 25%) to engage w...
Sr. Supplier Quality Engineer
Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products. Years' Experience Required: - years of Supplier Quality and Quality Engineering experienc...
Supplier Quality Engineer
Join a forward-thinking team in the medical device industry, where you'll drive product quality and supplier collaboration. Take ownership of supplier relationships and quality initiatives. Partner with suppliers to resolve quality issues with materials and components. Travel (up to 25%) to engage w...
Supplier Quality Engineer
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. Engineering experience and demonstrated use of Quality tools/met...
Supplier Quality Engineer
Join a forward-thinking team in the medical device industry, where you'll drive product quality and supplier collaboration. Take ownership of supplier relationships and quality initiatives. Partner with suppliers to resolve quality issues with materials and components. Travel (up to 25%) to engage w...
Supplier Quality Engineer
Join a forward-thinking team in the medical device industry, where you'll drive product quality and supplier collaboration. Take ownership of supplier relationships and quality initiatives. Partner with suppliers to resolve quality issues with materials and components. Travel (up to 25%) to engage w...
Supplier Quality Engineer
Join a forward-thinking team in the medical device industry, where you'll drive product quality and supplier collaboration. Take ownership of supplier relationships and quality initiatives. Partner with suppliers to resolve quality issues with materials and components. Travel (up to 25%) to engage w...