Massachusetts Veterans Jobs

Director of Quality System Architecture, Corporate

Marlborough, MA, United States

Responsible for ensuring Hologic has an overall robust and efficient Quality Structure of QMSs for current business and future acquisitions. Must develop and maintain a roadmap for the QMS structure that manages risk to the business, balances scale for current and future growth and maintains compliance to ensure patient safety.

Internally, the Director will be responsible to provide leadership to the Divisions and International team to establish a solid core QMS structure. Externally, the Director will work with the Hologic Notified Bodies to facilitate strategic plans.

Responsible to define, implement, maintain, and disseminate Key Performance Indicators, targets and provide visibility on the performance of the QMS systems.

Essential Duties

• Responsible to develop and maintain a roadmap for the QMS structure manages risk to the business, balances scale for current and future growth and maintains compliance to ensure patient safety

• Develop relationships with Notified Bodies utilized by Hologic including ensuring a regular cadence of meetings to allow for efficient communication and transparency

• Provide strategic oversight of QMS certifications for current and future businesses

• Provide SME

• Acts as a Hologic subject matter expert for QMS, MDSAP, CE and other quality certifications.

• Coordinate compliance activities and issues with Notified Bodies and European Competent Authorities.

• Collaborate with Divisions and International teams to maintain integrity of overall Quality System and sharing of best practices. .

• Responsible to perform assessments to identify gaps, plan and execute changes needed due to new or emerging regulatory changes.

• Provides continuing liaison support to M&A organization during assessment and acquisition phases.

• Work to achieve the overall objectives related to the areas of responsibility and strategic goals and translate into tactical plans for effective implementation.

• Interacts with senior management and collaborates across functions as needed to support company strategies and goals.

Qualifications

Education

• Bachelor’s Degree in business, engineering, or regulatory related discipline; or an equivalent combination of education and experience with a minimum of 10 years Medical Device Management Experience.

Experience

• 10+ years progressive related quality assurance experience including proven managerial and project management skills.

• Experience managing Quality System certificates and/or MDR/IVDR product certificates.

• Experience in effectively completing internal and external audits successfully within an FDA regulated cGMP facility

• Proven track record of building and promoting a culture of Quality that has resulted in engaged employees and resulted in world class customer experiences

Skills

• Demonstrated knowledge and understanding of regulatory requirements of a Medical Device or In Vitro Diagnostic organization

• Experience with International Regulations including but not limited to MDR, IVDR, EUDAMED, UKCA, Health Canada.

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 $154,200 to $274,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, 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 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, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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