Quality Specialist 3

Hologic•Marlborough, MA

11d

About The Position

Hologic is seeking a senior-level QMS Specialist to serve as a subject matter expert in CAPA, nonconformance, and quality compliance. The role drives compliant, sustainable QMS improvements, supports remediation and inspection readiness, and partners cross-functionally across regulated medical-device quality-system workstreams. It calls for hands-on SME ownership, strong analytical and technical-writing skills, and the ability to lead or support remediation, manage quality metrics, advise teams on complex quality issues, and communicate with director-level leadership. The position may require travel up to 15%, including potential international travel. The role requires 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 is required, with medical devices preferred. The annualized base salary range is $85,200–$133,300, and the position is bonus eligible. Hologic provides comprehensive onboarding training and continued development and training throughout the employee’s career.

Requirements

2–5 years of Quality Systems experience with a technical bachelor’s degree, or 1–3 years of Quality Systems experience with a master’s degree.
Experience in a regulated industry; medical-device experience is preferred.
Experience managing or working with CAPA, nonconformance, and other QMS processes across multiple sites.
Experience supporting QMS compliance workstreams, including CAPA, nonconformance, audits, change control, and quality data trending.
Experience supporting remediation in response to audit findings, inspection observations, enforcement actions, or continuous-improvement initiatives.
Experience preparing for or supporting FDA inspections, Notified Body or MDSAP audits, and internal audits.
Experience working cross-functionally with process owners, CAPA/NC owners, remediation leads, and quality teams.
Knowledge of QMS requirements in a regulated medical-device environment.
Knowledge of CAPA, nonconformance, and quality-compliance processes, methodologies, and best practices.
Knowledge of FDA 21 CFR 820/QMSR, ISO 13485, ISO 14971, EU MDR, MDSAP, and other applicable global regulatory standards.
Knowledge of root cause analysis, risk assessment, corrective actions, containment, disposition, and effectiveness checks.
Knowledge of internal and external audits, change control, management review, and quality data trending.
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, nonconformances, 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 the ability to provide executive-level updates and present to director-level leadership.
Ability to lead cross-functional teams and manage multiple workstreams.
Strong organization and program-management skills.
Hands-on, accountable approach with SME-level ownership; detail-oriented focus on compliance, effectiveness, sustainability, and quality.
Proactive identification of gaps, trends, systemic risks, and process-improvement opportunities; collaborative approach across functions, sites, and divisions.
Comfort advising teams on complex or systemic quality issues and operating in high-visibility, fast-paced environments.
Strong escalation judgment and a continuous-improvement mindset.
Ability to coach others and promote process adherence and regulatory expectations.
Ability to travel up to 15%, including potential international travel.

Nice To Haves

Experience in the medical-device industry.
Knowledge of statistics and statistical analysis.
Experience using Agile or an equivalent Product Lifecycle Management (PLM) system.
Experience using Qlik, PowerBI, or equivalent reporting tools.

Responsibilities

Serve as a subject matter expert for CAPA, nonconformance, and quality compliance processes.
Drive compliant, sustainable improvements to QMS processes and support remediation activities.
Support audit and inspection readiness, including FDA inspections, Notified Body audits, MDSAP audits, and internal audits.
Work cross-functionally with process owners, CAPA and NC owners, remediation leads, and quality teams across multiple sites and divisions.
Perform or support root cause analysis, risk assessment, corrective actions, containment, disposition, and effectiveness checks.
Support QMS workstreams including CAPA, nonconformance, audits, change control, and quality data trending.
Prepare and maintain regulatory documentation, investigations, CAPAs, nonconformances, and quality records.
Manage quality dashboards, metrics, reports, and performance tracking to support data-driven improvement.
Lead or support cross-functional teams and manage multiple workstreams.
Present updates to director-level leadership and communicate quality issues effectively.
Train, coach, and mentor junior staff and cross-functional teams.
Identify quality gaps, trends, systemic risks, and process-improvement opportunities; escalate CAPA, nonconformance, and compliance issues as appropriate.
Travel up to 15%, including potential international travel.