22 часа назад
Final Release Specialist (Medical Device Manufacturing)
22 - 31$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Final Release Specialist (Medical Device Manufacturing): Reviewing and completing manufacturing records and documentation for compliant batch final release with an accent on Device History Records, batch records, inspections, and regulatory requirements. Focus on tracking work-in-progress records, initiating nonconformances and CAPAs, resolving documentation issues, and coordinating release activities across Quality, Operations, Engineering, and other departments.
Location: Devens, MA, United States. Onsite first-shift role, Monday through Friday, 7:00am–3:30pm.
Hourly pay: $22–$31.
Company
develops and operates industrially scalable laser metal additive manufacturing and precision machining capabilities for aerospace, defense, medical, and other essential industries.
What you will do
- Set up, organize, review, and complete technical, batch, and final release records.
- Assign and track work-in-progress records through completion and coordinate priorities with Program Managers.
- Verify inspections, physical products, data entry, documentation, and final dispositions against specifications and requirements.
- Identify, document, and report nonconformances, deviations, QA variances, and documentation errors.
- Coordinate with Quality Assurance, Operations, Customer Service, Distribution, Engineering, and other departments to resolve issues and meet commitments.
- Develop and release controlled work instructions and identify improvements to the Final Release process.
Requirements
- 3+ years of experience in medical device manufacturing with direct responsibility for Final Release or Document Control.
- Experience reviewing Device History Records and Batch Records for completeness and compliance.
- Experience initiating, documenting, and tracking nonconformances, deviations, and CAPAs to closure.
- Ability to read and interpret engineering drawings, blueprints, and technical specifications.
- Knowledge of ERP and QMS electronic systems.
- Ability to work onsite in Devens, Massachusetts, during the first shift.
Culture & Benefits
- Medical, dental, vision, and life insurance.
- Generous paid time off.
- 401(k) plan with company match.
- Competitive salary and equity package based on skills, qualifications, and experience.
- Inclusive environment focused on quality, accountability, ownership, and continuous learning.
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