Quality Systems Specialist

Spirax-Sarco Ltd.•Devens, MA

7d•$55,420 - $83,130•Onsite

About The Position

This role sits within our Quality function. The Quality Systems specialist plays a critical role in governing quality processes, leading audits, ensuring ISO compliance, and embedding quality requirements across all site functions. The role acts as a quality subject‑matter expert, ensuring procedures, controls, and behaviors meet regulatory, customer, and corporate expectations. The position requires a strong understanding of regulated quality systems, exceptional documentation skills, and demonstrated internal auditing competency. This role ensures the Quality is compliant, effective, and audit‑ready, and supports site certification efforts.

Requirements

Quality background within manufacturing
Experience implementing, maintaining, and/or auditing ISO‑compliant Quality Management Systems
Bachelor’s degree in Life Sciences, Engineering, Quality, or related discipline.
Formal internal auditor or lead auditor training.
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

Ensure the site Quality Management System complies with ISO standards, regulatory requirements, 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

5% employer 401K contribution
50% match on up to 3% of your contributions for added financial security
16 weeks at 100% pay for parental leave
Gradual transition with a unique 80% work schedule while still receiving 100% of your pay for the first 6 months after parental leave
Generous vacation
Well-being days
9 observed holidays
1 floating holiday day
Up to 15 caregiver days
80 hours of annual sick leave
3 paid volunteer days each year
Offering of 3 healthcare plans with HSA contributions