Quality Engineer

Support Quality Management activities, as applied to design and manufacturing of medical devices. Assist the R&D and Technical Operations (Tech Ops) groups with design transfer, process qualification and supplier control activities during design and manufacturing of medical devices.

Primary Responsibilities:

• Provide relevant quality support to R&D and Tech Ops group during design transfer of new product/s and routine production.

• Collaborate with Tech Ops group to create/review the design transfer plan and its timely execution. Ensure the completeness of DMR (Device Master Records) in Alcresta eQMS system and the relevant documentation of the DMR at the Contract Mfg Organization (CMO).

• Support new equipment/process/site qualification at the CMO. Assist in process and software validation at the CMO, as necessary. Review process qualification plans, PFMEA, Control Plans, and associated reports.

• Create/review various design/manufacturing control related documents and ECOs in Alcresta eQMS system, as applicable.

• Support CMO in the transition from a manual DHR process to electronic DHR system, as applicable.

• Escalate quality issues to management, as needed and collaborate with Tech Ops group towards taking appropriate actions with the CMO to address the quality-related issues during design transfer and routine manufacturing.

• Support Tech Ops group to identify and eliminate risks that could impact the product quality. Participate in risk assessment activities to identify product quality and compliance risks, and to mitigate those risks.

• Collaborate with Tech Ops team to review Supplier-initiated deviations/variances, non-conforming material and its disposition, associated investigation according to agreed upon plan and escalation to CAPA, as necessary. Monitor the progress of supplier corrective action requests (SCARs) and their timely closure with the supplier.

• Participate in miscellaneous quality system activities, e.g. CAPA, NCR, Complaint investigation, as required.

Education and Experience:

• Bachelor's Degree in Science or Engineering required.

• 2+ years of experience in quality management and/or quality assurance in medical device or life science industry; experience in Drug or medical device GMP environment.

• Experience in manufacturing processes and methodologies.

• Experience with software validation preferred ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification preferred.

Key Skills and Competencies:

• Familiarity with quality management principles, risk management, and process qualification associated with medical device, biologics or pharmaceutical products.

• Familiarity with ISO13485:2016 standard, FDA 21 CFR Part 820, 21 CFR Part 11 and ISO 14971:2019 Risk Management requirements.

• Ability to work in a cross functional team as well as the ability to be a self-starter and motivated to work independently.

• Demonstrated ability to liaison with R&D and manufacturing resources.

• Working knowledge of Root Cause Investigation, CAPA, FMEA and statistical techniques/data analysis.

• Working knowledge in chemical/biological processes, injection molding and mechanical assemblies etc.

• Possess conceptual and analytical thinking, ability to write clearly and review content of design and validation documentation.

• Possess strong communication, teamwork, and organizational skills; Strong analytical and problem solving skills.

• Proficiency in computer technology and systems operation.

Additional Job Requirements:

• ~20% travel.

• Location - Waltham, Massachusetts.