Sr Quality Systems Specialist

Hologic is seeking a Senior Quality Systems Specialist to strengthen and sustain our Quality Management System (QMS) and quality this role youll work across engineering supply chain regulatory marketing and other functions to investigate process product and system issues support audits and inspections and help develop and refine quality procedures. Youll use data-driven tools to analyze trends support continuous improvement and ensure our systems are audit-ready. If you enjoy solving diverse quality challenges partnering cross-functionally and owning impactful quality system initiatives in a regulated environment this role is a strong fit.

Knowledge

• Working understanding of Quality Management Systems (QMS) especially Management Review Quality System audits CAPA nonconformances and quality planning.
• Knowledge and experience with ISO 13485 MDSAP EU MDR and 21 CFR 820/QMSR in a medical device or IVD environment.
• Familiarity with internal and external audit expectations and documentation needs (front-room/back-room).
• Understanding of GMP concepts and quality system processes such as Quality Agreements Quality Plans (QPLs) and Periodic Review.
• Beneficial: Basic understanding of statistics and statistical analysis for quality metrics and KPIs.
• Beneficial: Experience with Agile or equivalent PLM systems.

Skills

• Excellent computer skills including use of word processing spreadsheet and database applications (data entry querying and report generation).
• Strong technical writing skills for drafting procedures quality system documentation audit responses and investigation reports.
• Ability to apply auditing knowledge to help build robust audit-ready systems and documentation.
• Experience with Quality Management Systems particularly Management Review CAPA and quality system audits.
• Capable of documenting technical work and leading/assisting investigations and improvements in a GMP-regulated environment.
• Able to modify maintain and create procedures and processes related to QMS elements.
• Comfortable presenting materials and quality system status to director-level leadership.
• Strong interpersonal skills to collaborate with junior staff peers and senior stakeholders across the organization.

Behaviors

• Models Hologics quality values promoting defect prevention reduction of variation and waste and continuous improvement.
• Detail-oriented and thorough ensuring quality records procedures and outputs are accurate and compliant.
• Collaborative and communication-focused working effectively with cross-functional teams at all levels.
• Uses sound judgment in selecting methods and techniques to solve diverse quality system problems.
• Proactive and self-directed requiring little day-to-day instruction while responding effectively to new assignments.
• Comfortable networking with senior internal and external personnel within area of expertise.

Experience

• College Degree required; Technical Bachelors Degree preferred (e.g. Engineering Life Sciences or related field). With a non-technical college degree: 35 years in the medical device or IVD industry. Or with a technical Bachelors degree: 24 years of experience; 13 years with a Masters degree.
• Experience in a certified medical device or pharmaceutical manufacturing environment.
• Hands-on experience with QMS elements such as Management Review audits CAPA and quality planning.
• Experience supporting internal and external audits and/or FDA inspections is beneficial.

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 $85200-$133300 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 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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