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Regulatory & Quality Assurance
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At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health

What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.

None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.

While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.

 

Essential Duties and Responsibilities

  • Partners with the quality leadership in ensuring the implementation, effectiveness and integrity of the quality system is compliant to all applicable standards and regulations.
  • Manages the Corrective and Preventive Action (CAPA) system. – Performs the role of a CAPA facilitator, publishes reports, manages CAPA review board and educates team members on the CAPA process.
  • Manages the internal audit program – develops audit schedules, plans, and conducts internal audits to evaluate the effectiveness of the quality management system.
  • Oversee / manage the training system.
  • Develops and implements procedures to assure compliance with applicable quality system regulations and international standards.
  • Manages back room activities in support of third party Quality System inspections, including FDA, notified bodies and all other regulatory agencies as needed.
  • Provides training on quality system requirements, as necessary.
  • Compiles and analyzes quality system metrics (e.g. management review, CAPA Board and training effectiveness in order to ensure key process indicators are identified, measured and action driven.  Identifies unacceptable trends and drives suitable corrective action.
  • Leads and/or participates in multi-departmental teams to implement quality system improvements and/or quality plans.  Identifies specific action steps, accountabilities, and timelines for completion of projects as applicable.
  • Reviews and approves quality system document changes to ensure compliance to regulations is maintained.
  • Initiate and complete Quality System change orders in Agile as required.
  • May include other duties as defined by the Director of QA.

Qualifications  

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  

  • Must be computer literate: Microsoft Word, PowerPoint, Outlook and Excel.
  • Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations.
  • Excellent written, verbal and presentation skills.
  • Excellent interpersonal skills to interact with all levels of the company and oversight agencies, sometimes in an adversary role.

Education

  • Bachelor’s degree or equivalent combination of education and experience
  • Experience
  • Five to ten years related experience in an FDA regulated industry with at least three years recent experience in Medical Devices or equivalent combination of education and experience.

Specialized Knowledge

  • Excellent working knowledge of medical device regulations (21CFR, ISO13485, MDSAP and MDR/IVDR).
  • Certified Quality Engineer and/or Certified Lead Auditor.
  • Familiarity with the corrective action and internal audit processes related to the medical device industry

Additional Details  

  • Must be able to use hands and be mobile to get around production floor, engineering labs, warehouse and dock areas.
  • Vision abilities required include:  close vision, distance vision, color vision, depth perception and ability to adjust focus
  • Must be able to work independently and make decisions based on data and objective evidences.

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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