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 preparing for or supporting FDA inspections, Notified Body/MDSAP audits, and internal audits
Responsibilities
Serve as a Subject Matter Expert for CAPA, Nonconformance, and quality compliance processes
Drive compliant, sustainable QMS improvements and support remediation efforts
Ensure inspection readiness across regulated medical device quality system workstreams
Lead cross-functional teams to manage multiple workstreams effectively
Develop and implement corrective actions and effectiveness checks
Benefits
Opportunity to work in a dynamic, fast-paced environment
Collaborative culture with cross-functional partnerships
Professional development through training and mentorship
Exposure to high-visibility projects and executive-level communication
Potential for international travel opportunities
Full Job Description
Job Description
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
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.
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About Hologic
Hologic, Inc. is an American medical technology company that develops and manufactures diagnostic products, medical imaging systems, and surgical products. The company's products are used in a wide range of medical applications, including breast cancer screening, cervical cancer screening, and osteoporosis diagnosis. Hologic is headquartered in Marlborough, Massachusetts, and has operations in North America, Europe, and Asia. The company was founded in 1985 and has grown to become one of the largest medical technology companies in the world.
