13 days old

Quality Engineer

Marlborough, MA
  • Job Code
Job Opening - Quality Engineer - Marlborough, MA

Quality Engineer

job description

Our client is a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women; seeking a design focused Quality Engineer.

Essential Duties and Responsibilities
- Provide quality support for new product development activities of medical device products following design control requirements and internal procedures.
- Provides general engineering services and support for product manufacturing, quality control and new product development
- Compiles and analyzes quality system metrics (e.g. management review, compliance metrics, post market quality assurance, etc.) in order to ensure key process indicators are identified, measured and action driven. Identifies unacceptable trends and drives suitable corrective action
- Facilitate and actively contribute to the risk management activities per ISO 14971:2012: Risk Management Plans, FMEA's, Risk Control, etc. for new and released products.
- Supports Materials nonconformance investigation, disposition and release activity as applicable
- Write, review and/or approve reports for: test method validations, design verification, design validation, and process validations (IQ, OQ, PQ).
- Participate in supplier quality management assessment and qualification as required.
- Lead or participate in product, component or assembly qualifications at suppliers.
- Write, review and / or approved quality plans to support product activities both internal and external.
- Participate in project teams and company initiatives to assure compliance with Quality System requirements while achieving company objectives.
- Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE)

Working hours: Monday-Friday, normal working hours

--Detail-oriented with strong presentation, communication and organizational skills.
--Understands statistical analysis techniques.
--Proficiency in MS Office
--Excellent technical writing skills.

Education and Experience
--BS in Engineering or related technical science, M.S. is a plus.
--Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certificates from American Society for Quality (ASQ) are a plus
--5+ years of experience as a Quality Professional in the Medical Device industry required.

Specialized Knowledge
--Knowledge of ISO 13485 is essential as well as FDA and cGMP regulations and documentation practices

Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.


  • Engineering

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Quality Engineer

Randstad Engineering
Marlborough, MA

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Marlborough, MA

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