Quality Specialist 3

Hologic•Marlborough, MA

12d•$85,200 - $133,300

About The Position

Hologic is seeking a senior-level QMS Specialist to serve as a subject matter expert (SME) for CAPA, Nonconformance (NC), 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. The specialist applies knowledge of medical device quality systems and global regulatory standards to support CAPA and NC processes, audits, change control, management review, risk assessment, root cause analysis, corrective actions, and quality data trending. The role also supports remediation and inspection preparation, maintains quality metrics and reporting, provides regulatory documentation, and advises teams on complex or systemic quality issues. The position is an accountable, hands-on individual contributor who leads or supports cross-functional workstreams and coaches others. The role requires a technical bachelor's degree with 2–5 years of Quality Systems experience, or a master's degree with 1–3 years of experience. Experience in a regulated industry is required, with medical devices preferred. Travel may be required up to 15%, including potential international travel. Hologic provides comprehensive onboarding training and continued development and training. The annualized base salary range is $85,200–$133,300, and the role is bonus eligible. Final compensation depends on relevant experience, skills, knowledge, education, business needs, and market demand.

Requirements

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; medical device experience is preferred.
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 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.
Knowledge of QMS requirements in a regulated medical device environment.
Knowledge of CAPA, NC, 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.
Knowledge of audit and inspection readiness, quality metrics, dashboards, reporting tools, and data-driven continuous improvement.
Ability to serve as an SME for CAPA, NC, and quality compliance processes.
Strong root cause analysis, risk assessment, problem-solving, analytical, organization, and program management skills.
Ability to lead or support QMS remediation and develop sustainable corrective actions and effectiveness checks.
Strong technical writing skills for regulatory documentation and quality records.
Ability to manage dashboards, metrics, reports, and quality performance tracking.
Strong written and verbal communication skills, including executive-level updates and presentations to director-level leadership.
Ability to lead cross-functional teams, manage multiple workstreams, and coach and mentor others.
Ability to advise teams on complex or systemic quality issues and exercise sound escalation judgment.
Ability to travel up to 15%, including potential international travel.

Nice To Haves

Statistics and statistical analysis experience.
Experience with Product Lifecycle Management systems such as Agile or equivalent.
Experience with reporting systems such as Qlik, PowerBI, or equivalent.
Medical device experience.

Responsibilities

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