Senior Quality Assurance Engineer

Mykelly; North Billerica (MA); On-site; USD 76,000 - 117,000; Full time

Job summary

Kelly Science is seeking a Senior Quality Assurance Engineer for a contract-to-hire opportunity with a leading medical diagnostics company in Billerica, MA. This role emphasizes hands-on QMS remediation, regulatory compliance, risk management, and quality systems improvement within a highly regulated medical device environment, with a path to Design Assurance and NPD as remediation progresses.

The position requires onsite work 4-5 days per week and collaboration across Quality, Regulatory

Qualifications

• Bachelor's degree required in engineering, science, or related technical field.
• Minimum of 4 years of Quality Engineering experience in FDA-regulated medical device manufacturing.
• Hands-on experience with QMS remediation, quality system improvements, and regulatory compliance initiatives.

Responsibilities

• Lead QMS remediation initiatives, identify compliance gaps, implement corrective actions, and ensure sustainable audit findings resolutions.
• Assess, revise, and improve quality processes to ensure FDA and ISO compliance.
• Support internal/external/regulatory audits including responses and CAPA effectiveness verification.
• Drive CAPA, nonconformance management, change control, document control, and risk management process improvements.
• Perform risk management activities including FMEAs and risk analyses.
• Collaborate with Quality, Regulatory, R&D, Manufacturing, and Operations to close quality gaps.
• Review and improve quality documentation within a paper-based QMS environment.
• Support root-cause investigations and CPAs.
• Provide Design Assurance support for product development and changes.

Skills

QMS remediation

Regulatory compliance

CAPA & investigations

Design Controls

Risk management

FDA compliance

Documentation skills

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related field

Tools

MS Office Suite

Job description

Location: Billerica, MA
Job Type: Contract-to-Hire
Schedule: Onsite4-5 days per week, occasional flexibility for remote work 1 day per week

Kelly Science is seeking a Senior Quality Assurance Engineer for an exciting contract-to-hire opportunity with a leading medical diagnostics company in Billerica, MA.

This is an excellent opportunity for an experienced Quality Engineer to play a critical role in strengthening and improving Quality Management Systems (QMS) within a highly regulated medical device manufacturing environment.

The ideal candidate will bring hands‑on experience in QMS remediation, regulatory compliance, risk management, and quality systems improvement, along with the flexibility to thrive in a fast-paced, evolving environment.

This position will initially focus heavily on QMS remediation and compliance initiatives, with the opportunity to transition into Design Assurance and New Product Development (NPD) activities as remediation efforts progress.

Key Responsibilities

• Lead and support QMS remediation initiatives, including identifying compliance gaps, implementing corrective actions, and ensuring sustainable resolution of audit findings.

• Assess, revise, and improve quality processes and procedures to ensure compliance with FDA regulations, ISO 13485, ISO 14971, and applicable international regulatory requirements.

• Support internal, external, and regulatory audits, including audit preparation, responses, corrective action plans, and effectiveness verification.

• Drive continuous improvement efforts across CAPA, nonconformance management, change control, document control, and risk management processes.

• Conduct and support risk management activities, including FMEAs, risk assessments, Risk Priority Numbers (RPNs), and risk mitigation strategies.

• Collaborate closely with Quality, Regulatory Affairs, R&D, Manufacturing, and Operations teams to address quality system gaps and strengthen compliance.

• Review and improve existing quality documentation, procedures, and processes within a primarily paper-based QMS environment.

• Support root‑cause investigations and implementation of effective corrective and preventive actions.

• Provide Design Assurance support for product development, product changes, and sustaining engineering activities as remediation priorities evolve.

• Support end-to-end Design Controls, including design inputs and outputs, design reviews, verification and validation, design transfer, and design changes.

• Ensure quality and regulatory requirements are integrated throughout the product lifecycle.

Qualifications

Required:

• Bachelor's degree in Engineering, Science, or a related technical discipline.

• Minimum of 4 years of Quality Engineering experience within an FDA-regulated medical device manufacturing environment.

• Demonstrated hands‑on experience with QMS remediation, quality system improvements, and regulatory compliance initiatives.

• Strong working knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and ISO 14971.

• Experience with CAPA, nonconformances, root‑cause investigations, and corrective action implementation.

• Experience with risk management tools and methodologies, including FMEAs, risk assessments, and RPN scoring.

• Working knowledge of Design Controls and quality requirements throughout the product development lifecycle.

• Strong documentation, organizational, analytical, and problem‑solving skills.

• Ability to work independently, manage competing priorities, and adapt to changing business needs.

• Excellent communication and cross‑functional collaboration skills.

• Proficiency with Microsoft Office applications, including Excel, Word, Teams, SharePoint, and OneDrive.

• Ability to work onsite in Billerica, MA, 4-5 days per week.

Preferred:

• Experience within the In Vitro Diagnostics (IVD) industry.

• Familiarity with EU IVDR/MDR requirements.

• Experience supporting FDA inspections, regulatory audits, or significant quality system remediation projects.

• Experience with end-to-end Design Assurance and New Product Development (NPD).

• Experience working with paper-based Quality Management Systems.

• Experience improving quality processes in rapidly changing or highly regulated manufacturing environments.

What Makes This Opportunity Unique?

• High-Impact Work: Play a key role in a significant QMS remediation and quality systems improvement initiative.

• Cross-Functional Collaboration: Work directly with Quality and Regulatory leadership and partner with engineering, manufacturing, and regulatory teams.

• Professional Growth: Gain exposure to complex quality challenges, regulatory compliance initiatives, and Design Assurance activities.

• Long-Term Potential: Contract-to-hire opportunity with potential for permanent conversion as the remediation project progresses.

• Variety of Responsibilities: Initially focus on QMS remediation, with the opportunity to expand into Design Controls and New Product Development.

What We're Looking For

We're seeking a hands‑on, solutions‑oriented Quality Engineer who is comfortable navigating complex quality challenges and driving meaningful improvements. The successful candidate will be adaptable, highly organized, collaborative, and able to bring structure to an evolving environment.

If you have a strong background in medical device quality systems, enjoy solving complex compliance challenges, and want to make a measurable impact, we encourage you to apply!

Apply today through Kelly Science to learn more about this opportunity.

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