Quality Engineer

Job Title: Quality Engineer

Company: Novozen Health Care

Location: Danvers, MA

Employment Type: Contract

Job Responsibilities

• Provide quality support for service and repair operations, including nonconformances, CAPAs, change controls, and escalations.
• Translate compliance requirements into practical procedures and work instructions, including document content generation and redline facilitation.
• Investigate, document, and audit quality records to ensure compliance with applicable quality standards and regulations.
• Partner with operations teams to maintain compliance with medical device quality systems and regulatory requirements.
• Support internal and external audits and inspections related to service and repair activities.
• Improve quality processes, SOPs, and systems in alignment with industry standards.
• Identify quality risks, support issue resolution, and drive continuous improvement initiatives.
• Use Microsoft Excel for data analysis, data mining, and lookups.
• Navigate quality systems and collaborate with quality, operations, supply chain, and commercial teams.

Required Qualifications

• Bachelor’s degree in Engineering or a scientific discipline.
• 5 years of experience in a regulated industry, preferably medical devices.
• Hands-on experience with CAPA, nonconformance management, change control, and audits.
• Knowledge of medical device regulations, including FDA Quality System Regulation (QSR) and ISO 13485.
• Strong documentation, investigation, and quality record review skills.
• Proficiency in Microsoft Excel, including data mining and lookups.
• Strong communication skills and the ability to work cross-functionally in a fast-changing environment.
• Detail-oriented, self-directed, and capable of managing multiple priorities independently.

Preferred Qualifications

• Experience supporting service and repair or commercial quality operations.
• Exposure to global or multi-site quality environments.
• Experience with computer system validation (CSV) or quality IT systems.
• Familiarity with ISO 14971, EU MDR, or MDSAP.
• Six Sigma or other continuous improvement methodology experience.
• Master’s degree in Engineering, Science, or Business.

Pay Scale

Anticipated hourly pay range $40/hr to $45/hr on W2.

Benefits

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements.

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.