Quality Engineer II

Quality Engineer II

Location: Marlborough, MA (Onsite)

Employment Type: W2 / 12-Month Contract with possible extensions

Pay Rate: $50.00 - 55.00 per hour (based on experience)

Benefits: Medical, Dental, Vision, and Life Insurance

Note: This is a W2-only role No C2C or C2H candidates will be considered.

Role Overview

BEPC, Inc. is seeking a Quality Engineer II to join our clients Global Supplier Quality Organization in Marlborough, MA. This role will support supplier oversight activities, ensuring that all purchased components, materials, and services meet regulatory, quality, and performance requirements.

The Quality Engineer II will collaborate cross-functionally with R&D, Regulatory Affairs, Manufacturing, and Quality teams to ensure supplier compliance with ISO 13485 and FDA 21 CFR Part 820 standards. This position requires hands?on experience with CAPA, root?cause analysis, and validation (IQ/OQ/PQ), along with a strong understanding of medical device quality systems.

Key Responsibilities

• Execute activities to comply with ISO 13485, FDA 21 CFR Part 820, and internal QMS requirements.
• Conduct technical reviews of suppliers to evaluate manufacturing, process control, and quality assurance capabilities.
• Lead and monitor supplier performance, quality control practices, corrective actions, and continuous improvement initiatives.
• Review and approve PPAP documentation and ensure timely completion.
• Work cross?functionally with R&D and Design Assurance to verify that supplier parts meet fit, form, function, and reliability requirements.
• Issue and follow up on SCARs (Supplier Corrective Action Requests), SACAs, and NCEs within defined timelines.
• Perform root cause analysis and develop effective CAPA plans to prevent recurrence of supplier non?conformances.
• Support Health Risk Assessments, supplier qualification, and new supplier onboarding processes.
• Partner with Incoming Quality to assess supplier performance and determine eligibility for Skip Lot Programs.
• Maintain complete and compliant supplier quality records, metrics, and documentation in alignment with company and regulatory standards.
• Support internal and external audits as a subject matter expert on supplier quality.
• Collaborate with Post-Market Surveillance to address supplier?related field or product quality issues.
• Coordinate implementation of supplier changes, ensuring all modifications are documented through the formal change control process.
• Participate in supplier review meetings and generate performance metrics to drive quality improvement.
• Perform additional quality?related duties as assigned by management.
  

Qualifications

Education: Bachelors degree in Electrical or Mechanical Engineering is required.

Experience: 25 years of professional experience in quality or supplier engineering within a regulated industry, preferably medical devices.

Technical Skills

• Strong working knowledge of ISO 13485, CFR Part 820, and medical device regulations.
• Experience with CAPA, root cause analysis, and validation (IQ/OQ/PQ).
• Understanding of risk management (ISO 14971), statistical process control (SPC), and sampling methods.
• Familiarity with PPAP and Measurement System Analysis (Gage R&R) preferred.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).
• Knowledge of Agile PLM systems, Minitab, Project, or Visio (preferred).
  

Soft Skills

• Excellent verbal and written communication skills.
• Strong analytical and organizational abilities.
• Ability to manage multiple complex projects with minimal supervision.
• Demonstrated teamwork and cross?functional collaboration.
  

Other Requirements

• Ability to travel domestically and internationally as needed.
• Must comply with all safety and PPE requirements, including safety shoes in designated areas.
  

About BEPC

BEPC Inc., founded in 2007, is a 100% employee?owned company providing industry?leading consulting and staffing solutions across technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation, collaboration, and excellence, empowering professionals to make a lasting impact in their fields.

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