Quality Engineer, Design Assurance
3 weeks ago
Title: Quality Engineer, Design AssuranceLocation: Woburn, MADuration: 12+ MonthsJob 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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