QMS Specialist

Spirax-Sarco Ltd. • Devens, MA

1d • Onsite

About The Position

The Quality Systems Lead is responsible for designing, implementing, and maintaining the site’s Quality Management System (QMS) to meet ISO requirements. This role leads the internal and customer audit program, authors and revises QMS documentation, and drives compliance across all functions. The position requires a strong understanding of regulated quality systems, exceptional documentation skills, and demonstrated internal auditing competency. This role ensures the QMS is compliant, effective, and audit‑ready, and supports site certification efforts.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Quality, or related discipline.
• Formal internal auditor or lead auditor training.
• Experience implementing or auditing QMS compliant systems is highly desirable.
• Strong working knowledge of quality system elements: document control, training, risk management, CAPA, supplier management, validation, and production controls.
• Excellent written communication and technical writing skills.
• Ability to interpret regulations and translate them into practical procedures.
• High integrity, objectivity, and ability to challenge stakeholders constructively.
• Strong analytical, organizational, and problem‑solving skills.
• Ability to work independently and lead compliance activities across multiple departments.

Responsibilities

• Design, draft, and implement QMS processes, procedures, and templates compliant with ISO, regulatory expectations, and corporate quality policies.
• Maintain control of QMS documentation, ensuring structure, version control, and alignment with best practices and site needs.
• Collaborate with cross‑functional SMEs to ensure procedures reflect operational reality while meeting regulatory requirements.
• Support creation and maintenance of Quality Manuals, process maps, and QMS frameworks consistent with ISO expectations.
• Own the internal audit schedule and ensure full QMS coverage annually.
• Develop audit plans, criteria, scope, and checklists for process, system, and regulatory audits.
• Conduct audits independently and objectively across all organizational functions.
• Gather and evaluate objective evidence to assess compliance with QMS, and regulatory requirements.
• Document findings, classify nonconformities, and issue audit reports in alignment with internal standards.
• Track and verify corrective actions through closure, ensuring effectiveness.
• Train and mentor internal auditors as the program expand.
• Lead gap assessments between current practices and ISO requirements.
• Drive site readiness for certification and customer audits.
• Ensure all QMS elements, design control, calibration, risk management, training, document control, production control, CAPA, and supplier quality are implemented and audited appropriately.
• Participate in management reviews by preparing QMS performance metrics and compliance summaries.
• Partner with Quality Control team to investigate quality system nonconformities and identify systemic gaps.
• Provide guidance on root‑cause analysis and effectiveness verification.
• Recommend and champion quality system improvements using audit outcomes and risk-based methodologies.
• Provide training to employees on QMS processes, documentation, audit readiness, and quality system expectations.
• Collaborate with cross-functional roles (Engineering, Production, Supply Chain, Quality Control) to ensure seamless implementation of QMS requirements.
• Serve as the on‑site expert for QMS structure and ISO interpretation.
• Supervise the site Document Control & Training Coordinator.
• Other duties as assigned.

Benefits

• Robust Retirement Plan: Benefit from a 5% employer 401K contribution, plus a 50% match on up to 3% of your contributions for added financial security, empowering your financial security.
• Comprehensive and Supportive Parental Leave: Experience our inclusive, gender-neutral parental leave policy, offering 16 weeks at 100% pay. Upon your return, enjoy a gradual transition with a unique 80% work schedule while still receiving 100% of your pay for the first 6 months, ensuring a balanced reintegration into the workplace.
• Generous Time Off: Enjoy ample time off to recharge and attend to life's circumstances with generous vacation and well-being day, 9 observed holidays, 1 floating holiday day, up to 15 caregiver days, and 80 hours of annual sick leave.
• Community Engagement Opportunities: Make a difference with 3 paid volunteer days each year, encouraging you to give back to the community and causes you care about.
• And Many More Benefits: Such as an offering of 3 healthcare plans with HSA contributions along with other benefits designed to support your well-being and professional growth. We invite you to explore all the ways we strive to create a fulfilling and rewarding work environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level