Quality Engineer

Job Title : Quality Engineer
Location: Waltham, MA

• Maintain and improve the Quality System to ensure compliance with ISO standards, QSR Regulations, and MDSAP.
• Provide front and backroom support during external regulatory body audits and factory inspections such as FDA, TUV, Partners, and Customers.
• Generate and review Validation Protocols and Reports (IQ, OQ, PQ) for adequacy, completeness, and compliance with Quality Systems requirements.
• Drive Quality Planning activities in support of new product launches and Quality System improvements.
• Participate in problem-solving activities to determine root cause and effective corrective action and other CAPA activities.
• Perform and assist with internal investigations (NIRs) for customer complaints and/or deficiencies identified internally.
• Review and approve nonconforming material reports, artwork proofs, and First Article Inspections.
• Create and update Standard Operating Procedures (SOPs).
• Prepare and review Engineering Change Orders (ECO) and Manufacturing Variances (MV).
• Participate in the identification, planning, implementation, and monitoring of continuous improvement projects to reduce defects and improve overall product quality.
• Manage and maintain quality data including design and validation of new or existing databases, queries, and reports.
• Prepare, present, review, and analyze quality data with SMEs to identify trends and draw effective conclusions.
• Provide general oversight and training on Quality procedures and practices.

• Certifications are not required but Certified Quality Auditor and/or Certified Quality Engineer is a plus.
• Excellent oral and written communication.
• Read and interpret technical documents.
• Exercise judgement in selecting methods and techniques for obtaining results and problem solving.
• Advanced math skills and sound understanding of statistical analysis; previous experience with Statistical software (e.g., Minitab) is a plus.
• Advanced computer knowledge and proficiency with Microsoft Office tools.
• Basic knowledge of FDA QSR, MDSAP, IVDD/IVDR, and ISO 13485.

• BS degree in engineering, the sciences, or another technical discipline.
• 1-2 years of quality engineering experience in the medical device and/or biotechnology fields, or equivalent.