Sr Quality Engineer - Entegee

Job Summary:
Seeking a Senior Quality Engineer to develop and maintain quality plans, inspection systems, and provide support in pre-production and production-ready manufacturing in the medical device sector.

Job Requirements:

• Experience with Process Validation (IQ, OQ, PQ)
• Knowledge of Risk Management, including Risk Analysis and Risk Assessment
• Proficient in Statistical Analysis, preferably using Minitab or SPC
• Experience with CAPAs (Corrective and Preventive Actions)
• ASQ Certification
• Familiarity with Canadian Medical Device Regulation (CMDR)
• Understanding of EU Medical Device Directive (EU MDD 93/42 EEC)
• Experience in a Disposable Medical Device Environment
• Six Sigma Certification or Lean Principles training
• Ability to work hybrid with 3 days onsite and 2 days remote

Preferred Skills:

• Specialization in areas of design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality

Job Responsibilities:

• Develop and modify quality standards and protocols for processing materials into partially finished or finished products
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place
• Perform risk assessment activities to identify and mitigate product quality or compliance risks
• Assist with and implement process validation procedures in accordance with QSR, FDA, and international guidelines
• Devise and implement methods for inspecting, testing, and evaluating precision and accuracy of products and production equipment
• Design or specify inspection and testing mechanisms and equipment, conduct quality assurance tests, and perform statistical analysis to assess cost and determine responsibility for non-compliant products
• Implement approved changes using quality engineering principles and document them in compliance with Quality System Regulation (QSR 21 CFR 820), ISO 13485:2003, and Corporate Policies
• Ensure corrective measures meet reliability standards and that documentation complies with requirements

Pay Details: $40.00 to $54.00 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.