Quality Engineer (Medical Device) | Devens, MA| Onsite

Title: Quality Engineer (Medical Device)

Location: Devens, MA| Onsite

Duration: 6-12+ Months

Job Summary

• A fast-growing manufacturing company is seeking a Process Validation resource to support their expanding operations team. This individual will be responsible for leading and executing activities across manufacturing processes, with a focus on developing and implementing robust validation protocols, conducting PFMEAs, and ensuring test methods are accurate, repeatable, and compliant with industry standards.

Key Responsibilities

• Develop and execute process validation plans, protocols, and reports for new and existing manufacturing processes.
• Lead and facilitate Process Failure Modes and Effects Analysis (PFMEA) sessions to identify and mitigate risks.
• Design and validate test methods to ensure product quality and regulatory compliance.
• Collaborate with cross-functional teams including Quality, Engineering, and Manufacturing to support continuous improvement initiatives.
• Analyze data from validation activities and provide recommendations for process optimization.
• Maintain documentation in accordance with internal procedures and regulatory requirements.
• Write and maintain detailed work instructions, standard operating procedures (SOPs), and process documentation to ensure repeatable and high-quality production.

Required Qualifications

• 10 years of experience in process validation.
• Medical Device experience (not Pharma).
• Orthopedic experience.
• Experience with FMEAs.
• IQ, OQ, PQ experience.

Best regards,

Lavesh Kumar

| Sr. Technical Recruiter

STELLENT IT A Nationally Recognized Minority
Certified Enterprise

Phone: +1

Email:

Gtalk:

LinkedIn: