Quality Engineer (Medical Device) | Devens, MA| OnsiteStellent IT LLC • Harvard, MA, US
No longer accepting applications
Quality Engineer (Medical Device) | Devens, MA| Onsite
Stellent IT LLC • Harvard, MA, US
1 day ago
Job type
- Full-time
Job descriptionDevelop 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. 10 years of experience in process validation. Medical Device experience (not Pharma). Orthopedic experience. Experience with FMEAs. IQ, OQ, PQ experience.
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
Required Qualifications
J-18808-Ljbffr
Create a job alert for this search
Quality Engineer • Harvard, MA, US