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Job Requirements of Quality Engineer III:
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Employment Type:
Full-Time
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Education:
High School
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Location:
Holyoke, MA (Onsite)
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Quality Engineer III
This role supports manufacturing operations by ensuring strict adherence to quality system, regulatory, and documentation requirements for highly regulated products while monitoring production for compliance and product integrity. It also leads validations, risk analyses, CAPA activities, and continuous‑improvement initiatives while partnering cross‑functionally to strengthen processes and resolve quality issues.
Client Details
This organization is a global manufacturer specializing in the design, development, and production of complex medical devices and components. It offers fully integrated, end‑to‑end capabilities-from engineering and prototyping to full‑scale manufacturing, assembly, packaging, and sterilization-serving a wide range of clinical applications. With thousands of employees across more than 20 international locations, it provides the scale, cleanroom capacity, and technical depth needed to support highly regulated, life‑saving medical technologies. The company focuses exclusively on med‑tech, combining advanced engineering expertise with robust quality systems to help bring innovative devices to market efficiently and reliably.
Description
- Develop and implement quality control processes to meet regulatory and customer requirements.
- Analyze performance data to identify areas for improvement in engineering and manufacturing processes.
- Collaborate with cross-functional teams to resolve quality issues and implement corrective actions.
- Ensure compliance with industry standards and regulations in all quality-related activities.
- Conduct audits and inspections to monitor and maintain quality standards.
- Train and mentor team members on quality assurance best practices and procedures.
- Prepare detailed quality reports and present findings to management and stakeholders.
- Drive continuous improvement initiatives to enhance product quality and operational efficiency.
Profile
A successful Quality Engineer III should have:
- BS Degree in related discipline or High School Diploma with 10+years of relevant experience.
- 5-8 years of relevant experience, preferably in the medical device industry.
- Ability to work cross-functionally and as a part of a project team.
- Experience in ISO 13485 industry.
- Ability to conduct root cause investigations using techniques such as FMEA, Fishbone, 5 Why, and 8D.
- Required experience with process validation (IQ, OQ, PQ, TMV).
- Proficiency in statistical tools (e.g., Gage R&R, Capability Analysis, ANOVA); Minitab experience is a plus.
- Proficiency in analyzing performance data and implementing improvement strategies.
- Excellent problem-solving skills and attention to detail.
- Effective communication and collaboration skills to work with cross-functional teams.
- Proven ability to lead quality improvement initiatives and mentor team members.
Job Offer
- Competitive salary range of $95,000 to $110,000 annually.
- Opportunities for professional growth and development.
- Comprehensive medical, dental, and vision benefits.
- Company-paid life insurance and disability benefits.
- Generous paid time off (vacation, Sick leave, holidays).
- 401k plan with company match.
- Supportive and collaborative work environment.
- Tuition reimbursement
- Voluntary benefits including life insurance long-term care, and legal coverage.
If you are passionate about quality assurance and eager to contribute to a growing organization, we encourage you to apply!
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.