Quality Specialist 3

Hologic; Marlborough (MA); On-site; USD 85,000 - 133,000; Full time

Job summary

Hologic, Inc. is seeking a senior-level QMS Specialist to act as SME for CAPA, NC, and quality compliance across regulated medical device workstreams.

The role focuses on driving compliant, sustainable QMS improvements, remediation support, and inspection readiness while partnering across cross-functional teams. The candidate will apply knowledge of FDA 21 CFR 820 / QMSR, ISO 13485, ISO 14971, and other global standards, lead root cause analyses, implement corrective actions, and monitor

Qualifications

• Experience in a regulated medical device environment with QMS
• CAPA, NC, and quality compliance processes experience
• FDA 21 CFR 820 / QMSR, ISO 13485, ISO 14971, EU MDR, MDSAP familiarity
• Root cause analysis, risk assessment, corrective actions, and effectiveness checks
• Internal and external audits, change control, and data trending
• Audit/inspection readiness including FDA and Notified Body audits
• Quality metrics, dashboards, and data-driven improvement
• Statistical analysis experience preferred
• PLM systems and metric reporting tools experience
• Ability to travel up to 15% (including international)

Responsibilities

• Serve as SME for CAPA, NC, and quality compliance processes
• Lead or support remediation of QMS processes and records
• Prepare regulatory documentation and investigations
• Develop sustainable corrective actions and effectiveness checks
• Manage dashboards, metrics, and quality performance tracking
• Provide executive-level updates and cross-functional leadership
• Lead cross-functional teams across multiple sites and workstreams
• Train, coach, and mentor junior staff
• Support remediation activities in response to audits and inspections

Skills

SME leadership

CAPA & NC ownership

Regulatory compliance

Root cause analysis

Data-driven improvement

Cross-functional collaboration

Executive communication

Training & mentoring

Program management

Detail-oriented

Education

Bachelor’s degree in technical field

Master’s degree in technical field

Tools

Qlik

PowerBI

Agile/PLM systems

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 auditsExperience 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.

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