Quality Engineer, Design Assurance

3 weeks ago

Woburn, United States TalentBurst Full time
Title: Quality Engineer, Design Assurance
Location: Woburn, MA
Duration: 12+ Months

Job Summary:
We are seeking a skilled Design Assurance Engineer or Systems Engineer to join our team as a contractor for a 9-12 month term. Reporting to the Director of QA/RA, the Quality Engineer, Design Assurance will establish and organize 21CFR820.30 compliant Design History Files and IVDR Class A Technical Documentation for existing Covaris systems. The ideal candidate will be a self-motivated professional with a strong background in engineering and a commitment to excellence . This position will require candidate to be on site at least 3 days a week. The contractor operates in support of ISO 13485 certification and IVDR remediation.

Responsibilities include:
  • Actively support product development initiatives with Design Assurance services including authoring documentation.
  • Support Product Development with quality documentation as needed.
  • Escalate potential issues that could impact compliance.
  • Establish technical documentation in support of IVDR Class A systems.
  • Establish System Level Design History Files
  • Identify and fill gaps in historical records.
  • Perform design verification and validation activities as needed.
  • Establish system level risk management files.
  • Perform other duties as assigned.

Essential Responsibilities: The employee may be required to perform all or a combination of the following essential responsibilities as determined by business necessity.
  • Conduct investigations of identified problems with existing products in the field and production. Use Complaints, NCMR, CAPA, and DCO processes to modify product design or manufacturing procedures as required.
  • Administer and improve quality processes, with a focus on Lean process management.
  • Assist manufacturing and product development with documentation, guidance, and execution of design verification/validation and process validation.

Non-Essential Responsibilities: The employee may be required to perform other non-essential functions, follow any other job-related instructions, and perform any other job-related duties requested by their supervisor.

Qualifications:
  • Bachelor's degree (minimum) in an engineering, technical or scientific discipline or equivalent.
  • Pragmatic, entrepreneurial personality and strong self-starter. Continually strives to improve.
  • A minimum of 5+ years of working experience in Design Assurance or Systems Engineering.
  • Excellent technical writing skills
  • Understand design controls, change controls, phase gated product development processes.
  • Demonstrated track record with 21 CFR 820.30, ISO 13485, the IVDR (Class A) and ISO 14971.
  • Demonstrated track record implementing risk management files.
  • Able to create multi-source reports, trends, and interpret data with minimal oversight.
  • Communicates effectively both verbally and in writing
  • Acts decisively with Integrity and Kindness.

Note: The candidate must be a contractor and possess flexibility in their schedule to accommodate the standardized 40-hour workweek at the Woburn, MA corporate office.

#TB_EN

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