AI use among inspectors, testers, sorters, samplers, and weighers is little observed so far. Measured exposure for inspectors, testers, sorters, samplers, and weighers: 3% (little observed).

Share of this job’s tasks that AI is already used for at work, from real usage. It is not a forecast of job loss, and a low number means no use seen yet. Source: Anthropic Economic Index.

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About the job

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 workstreams.

Knowledge

Quality Management System (QMS) requirements in a regulated medical device environment

CAPA, 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 workstreams

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

Experience

2–5 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 workstreams, 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 Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $85,200 - $133,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Agency and Third-Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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