Quality Engineer

We are seeking a Quality Engineer  to support projects and day-to-day manufacturing operations within a regulated environment. The ideal candidate will have 2–4 years of experience, with knowledge in nonconforming product handling, SPC, process validation, and quality documentation.

Employment Type:  Full-Time (On-site)
Shift:  1st and 2nd Shift
Schedule: Must be able to work extended hours, holidays and weekends
Minimum Requirements:

• Education:  Bachelor's Degree in Engineering.
• Experience:  2–4 years of relevant experience in the Medical Device or regulated manufacturing industry.
• Basic knowledge of quality operations in manufacturing, including nonconforming product handling, yield improvement, Pareto analysis, and defect bounding.
• Familiarity with Statistical Process Control (SPC).
• Fundamental understanding of Process Validation principles.
• Requires skills in statistical analysis (Minitab).

Responsibilities:

• Support Engineering and Quality teams in projects and day-to-day manufacturing operations.
• Work with Quality Systems, including the development, implementation, and/or evaluation of process nonconformities, CAPAs, and deviations.
• Review and assess Failure Modes and Effects Analysis (FMEA) for both suppliers and manufacturing processes.
• Develop, review, and manage quality and validation documentation, including change control processes and execution of validation protocols (IQ, OQ, PQ, etc.).

Benefits:

• Dental insurance
• Employee assistance program
• Employee discount
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Vision insurance

Work Location: In person