Quality Specialist

Position: Quality Specialist 3
Job-:
Quality & Regulatory Affairs

Location:

Marlborough, MA, United States

Schedule:

Full time Posted:
We are looking for senior-level QMS Specialist responsible for serving as a CAPA, Nonconformance, and Quality Compliance SME to drive compliant, sustainable QMS improvements, support remediation and inspection readiness, and partner cross-functionally across regulated medical device quality system work streams.

Knowledge Quality Management System (QMS) requirements in a regulated medical device environmentCAPA, Nonconformance (NC), and quality compliance processes, methodologies, and best practices FDA 21 CFR 820 / QMSR, ISO 13485, ISO 14971, EU MDR, MDSAP, and other applicable global regulatory standards

Root cause analysis, risk assessment, corrective actions, containment, disposition, and effectiveness checks

Internal audits, external audits, change control, management review, and quality data trending

Audit and inspection readiness, including FDA inspections, Notified Body audits, MDSAP audits, and internal audits

Quality metrics, dashboards, reporting tools, and data-driven continuous improvement

Statistics and statistical analysis, preferred

Product Lifecycle Management systems such as Agile, preferred

Reporting systems such as Qlik, PowerBI, or equivalent tools

Skills

Ability to serve as a Subject Matter Expert for CAPA, NC, and quality compliance processes

Strong root cause analysis, risk assessment, problem-solving, and analytical skills

Ability to lead or support remediation of QMS processes, procedures, and records

Strong technical writing skills for regulatory documentation, investigations, CAPAs, NCs, and quality records

Ability to develop sustainable corrective actions and effectiveness checks

Ability to manage dashboards, metrics, reports, and quality performance tracking

Strong written and verbal communication skills, including executive-level updates

Ability to present information to director-level leadership

Ability to lead cross-functional teams and manage multiple work streams

Ability to train, coach, and mentor junior staff and cross-functional teams

Strong organization and program management skills

Behavior

Hands-on, accountable individual contributor with SME-level ownership

Detail-oriented with a strong focus on compliance, effectiveness, sustainability, and quality

Proactive in identifying gaps, trends, systemic risks, and process improvement opportunities

Collaborative and able to partner effectively across functions, sites, and divisions

Comfortable advising teams on complex or systemic quality issues

Adaptable and able to operate in high-visibility, fast-paced environments

Strong escalation judgment for CAPA, NC, and compliance issues

Continuous improvement mindset

Able to coach others and promote process adherence and regulatory expectations

Experience2–5 years of Quality Systems experience with a technical bachelor’s degree, or 1–3 years with a master’s degree

Experience in a regulated industry, preferably medical devices

Experience managing or working with CAPA, NC, and other QMS processes across multiple sites

Experience supporting QMS compliance work streams, including CAPA, NC, audits, change control, and quality data trending

Experience supporting remediation activities in response to audit findings, inspection observations, enforcement actions, or continuous improvement initiatives

Experience preparing for or supporting FDA inspections, Notified Body/MDSAP audits, and internal audits

Experience working cross-functionally with process owners, CAPA/NC owners, remediation leads, and quality teams

Experience using Agile or equivalent PLM systems

Experience using Qlik, PowerBI, or other metric reporting systems

Ability to travel up to 15%, including potential international travel

Why join…