Senior Director, Quality
3 weeks ago
The Senior Director, Quality manages the development, implementation, and maintenance of Quality System processes. This position will interface with cross-functional departments facilitating resolution of events in compliance with divisional and corporate requirements. As a leader, the candidate is expected to effectively lead and mentor.
Essential Duties and Responsibilities
•Manages processes and teams associated with control of nonconforming products, CAPAs, deviations, complaints management, complaint investigations, post-market surveillance, audits, quality system, document control, incoming inspections, product release, and other Quality Assurance related processes and teams.
•Ensures the risk management program is state-of-the-art.
•In partnership with the VP of Quality, establishes overall short and long-term quality strategy and objectives.
•Prepares operating and capital budgets which include resource requirements.
•Interfaces with other departments and partners to ensure implementation of good compliance practices.
•Interacts and leads teams made up of other site leaders to improve the Agile system and shared processes.
•Initiates and manages projects to continuously improve and increase efficiency of quality processes.
•Prepares for and leads third party regulatory and supplier audits and inspections.
•Establishes, monitors, and reports key process indicators and drive actions as needed.
•Manages data analytics associated with collected/compiled data.
•Develops and manages trending programs.
•Establishes and manages training programs focused on cGMP, QMS, defect awareness, Quality at the Source, and other training programs that promote quality awareness and understanding.
•Ensures compliance to site, corporate, and regulatory requirements as defined by applicable regulatory bodies and agencies.
•Monitors development of new or updates to existing regulations and accurately and effectively translates them into workable processes and procedures.
•Promotes awareness of regulatory and customer requirements.
•Promotes the Culture of Quality throughout the organization.
•Works across sites to harmonize and/or align processes.
•Supports the ongoing development and implementation of a Corporate Quality System.
•Creates reports for and manages meetings covering Management Reviews.
•Manages projects and/or cross functional teams as needed.
•Creates bench-marking opportunities to seek best practices with the intention to improve internal processes.
•Motivates and manages teams for high engagement and performance.
•Develops and manages budget.
•Other duties as assigned.
Qualifications
Education:
•Bachelor degree required in life sciences, physical sciences, engineering or applicable technical field.
•ASQ Certification or equivalent experience desired
Experience:
•A minimum of 8-10 years in Quality Assurance/Regulatory Compliance management for the design, production, and on-market support of medical or IVD products
•Proven track record in leading multiple teams effectively
•Successful experience managing senior and mid-level leaders
Skills/Knowledge:
•Strong understanding of applicable regulations, such as but not limited to, the Medical Device Regulations, IVD Regulation, QSR, ISO 13485, ISO 14971, MDSAP, MDDAP, etc.
•Knowledge of Operational Excellence and Shingo Model desired
•Strong aptitude for troubleshooting mechanical and assay specific events partnering with others through resolution.
•Extremely intuitive with problem solving and resolutions utilizing risk management tools.
•Excellent attention to detail and ability to multi-task.
•Proven people manager and able to work with minimum supervision.
•Excellent verbal and written communication skills.
•Must be able to develop, lead, and motivate a team within a fast-paced manufacturing and design setting.
The annualized base salary range for this role is $174,000 to $249,400 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
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.
Hologic is an equal opportunity employer inclusive of female, minority, disabled and veterans, (F/M/D/V)
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