Quality Engineer II

About the role

The Quality Engineer will provide support for manufacturing commercial products through review and approval of Change Controls, CAPAs, and Deviations. They will support new product development as needed and participate in customer and regulatory audits as part of the Audit Team, tracking implementation of internal and external audit observations for on-time closure. The Quality Engineer works closely with Operations, Manufacturing Engineering, and Research & Development to ensure manufacturing of effective and high-level product quality while implementing efficient corrective and preventive action plans.

Responsibilities

• Review and approve CAPAs and Change Controls.
• Manage Internal and External Audit programs and maintain associated tracking logs, including capability within the Electronic Quality Management system.
• Evaluate and improve audit programs to ensure compliance with regulatory requirements.
• Perform internal audits as assigned and track implementation of audit observations for on-time closure.
• Lead investigations, perform root cause analysis, prepare detailed investigation reports, and implement corrective actions as needed.
• Perform QA review of new and revised procedures, technical protocols, validations, and reports.
• Participate in the development of customer requirements and design inputs, ensuring customer requirements (user needs) can be validated and design requirements can be verified.
• Facilitate the Risk Management Process in accordance with ISO 14971, ensuring integration of risk management outputs with design, process, and regulatory requirements.
• Design and maintain procedures and systems for process and quality data collection.
• Conduct and/or support process capability evaluations, determining critical process control points and appropriate control limits.
• Support equipment and process validation methods to ensure proper validation prior to implementation and periodic re-validation of critical equipment.
• Conduct gap analyses of in-house practices versus relevant regulations, standards, and industry practices; develop plans and implement corrective actions for continued compliance.
• Act as the SME trainer for other QA personnel.
• Perform other related duties as assigned.

Requirements

• Bachelor’s Degree in engineering or equivalent experience.
• Minimum of 3 years of related experience with demonstrated working knowledge of scientific principles in medical device manufacturing.
• Prior experience with review and approval of process change controls, CAPAs, and Internal/External Audits.
• Strong knowledge of statistical process control methods and techniques.
• Working knowledge and demonstrated application of ISO 14971 Risk Management for Medical Devices.
• Knowledge of GMP/ISO requirements, specifically current ISO 13485 Medical Devices.
• Knowledge of FDA 21CFR, EU, TGA (Australia), and ANVISA (Brazil) regulations.
• Working knowledge of cGMPs, QSRs, MDDs, and MDR.
• Familiarity with the principles of Design Control.
• Working knowledge of Electronic Quality Management Systems.
• Working knowledge of Six Sigma (a plus).
• Strong writing and presentation skills.

Pay

Salary range: $84,000 – $105,000

Benefits

• Discretionary bonus program for all full-time employees.
• Comprehensive healthcare benefits and health savings account.
• 401(k) plan with up to 5% company match (immediate vesting).
• Employee stock purchase plan at a 15% discount.
• Accrued paid time off.
• Additional long-term incentives including stock awards.

Location: Bedford, MA
Employment Type: Full-Time