Supplier Quality Engineer - Entegee

Job Requirements:

• Engineering Degree with experience in Manufacturing Engineering or Project Management.
• Hands-on experience with process validation IQ, OQ, and PQ.
• Experience in global project management within the medical device industry (Medtronic, Abbot, Stryker, Boston Sci, Baxter, etc.).
• Minimum of 1-year role stability in previous positions.
• Experience with ISO 13845.
• Proficiency in macro and micro-engineering skills.

Preferred Skills:

• Product Quality Engineering or Manufacturing Engineering experience in a lead role.
• Experience in supplier audits and supplier qualification.
• Knowledge of CPK, APQP, Process Capability Statistics, and Six Sigma.
• Experience with electro-mechanical and stent commodities.

Job Responsibilities:

• Act as SQE lead to drive supplier qualification and part qualification for Vasper products.
• Monitor supplier quality performance and develop quality processes relating to supplier quality control.
• Assist in supplier audits and supplier qualification, assessing supplier capabilities and adherence to design outputs.
• Drive supplier improvement via Supplier Quality Improvement Plans (SQIP).
• Work cross-functionally with R&D, design engineers, and suppliers on component and device designs.
• Ensure compliance with GMP practices and FDA regulations.
• Implement FDA or regulatory requirements as necessary.
• Travel between 25-50%, with some international travel possible.
• Provide routine department status updates to management.
• Responsible for supplier metrics for business unit reviews.

Pay Details: $30.00 to $50.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.