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Lead Post Market QA Analyst

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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.

Summary

A Health Care Professional responsible for managing the Adverse Event program and supports the Health Hazzard Evaluation (HHE) process. This individual will receive, review, and process all product complaints for manufactured and distributed products as required by applicable regulations, standards, and company policy. This position combines skills in post market regulations, statistics, and product knowledge in the process of trending and handling incoming complaints.  Partners with Product Support, Quality Engineering, Medical Affairs and other departments to support the overall Post Market Surveillance process.

Essential Duties and Responsibilities

  • Can perform all the essential duties of Post Market Surveillance Specialists
  • Responsible for review and final decision making of escalated complaints to determine reportability of medical complaints
  • Facilitators on moderate to complex complaints with potential field action implications 
  • Ensure customer communications are created and issued; review customer responses for technical accuracy related to Hologic products
  • Follow-up with the end users / customers for any additional information to support investigations
  • Lead and facilitates cross functional meetings and creates meeting minutes with little supervision
  • Assess medical complaints and assure timely decision making and reporting
  • Work with international QA/RA on device Vigilance complaints
  • Engage owners on determination of effective CAPA
  • Works with Medical Affairs and Engineering to perform risk assessments
  • Works on problems of complex and major scope where analysis of situation or data requires a review of a variety of factors
  • Works with Post Market Surveillance Specialists and Post Market Surveillance Engineers to ensure consistency in documenting complaints
  • Ensures that complaints are assessed from MDR within 3 days of receipt
  • Participate in external & internal audits
  • Exercises judgment within defined procedures and practices to determine appropriate action
  • Works with R&D to determine specific product and incident complaint codes
  • Works between PMSS and PMSE to ensure timely coding of completed investigations, closure of all complaint files, and ensures that all pertinent information is contained consistently and uniformly within the file prior to closure
  • Strives to meet Accuracy Goals (95% accuracy goal). Ensures data is collected through routine business processes and reviewed for accuracy, timeliness, relevance, completeness, understood by users, and quality
  • Lead new hire training on Potential Adverse Event complaints and MDR
  • Creates or update QMS documents as needed
  • Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
  • Assists with various projects as assigned.
  • Other duties as assigned

Qualifications 

 

Education

  • Bachelor's degree in medical science, health sciences or healthcare related field

Experience

  • Minimum of 3-5 years of clinical experience.
  • Registered Nurse or CRNA or Registered Radiologic Technologist with related experience in the healthcare/device industry or exposure to medical device quality system regulations understanding of drug/device safety requirements are required; with an Advanced Degree no prior experience may be considered. 
  • Experience on MDR and BPDR submissions (preferred)
  • Understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820.198 and 21 CFR 211).
  • Prior experience processing medical device or drug complaints strongly preferred.
  • Strong interpersonal skills.
  • Knowledge based PC computer skills essential, such as industry recognized complaint management systems, MS Access and Excel.

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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