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Senior Quality Assurance Engineer

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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.


Job Summary
  • Provide quality assurance leadership/support to the implementation, maintenance, and improvement of the Quality Management System, including process validation, part/ process qualification, Internal Audits, CAPA, Training, and Supplier Management. Provide quality assurance support to the compilation, analysis, and presentation of post-market Quality data, including Management Review, Risk Management Board, Complaint Review, NCR reviews, and Supplier Performance reviews.
 
Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. 

  • Lead/ support manufacturing for all process changes, assuring appropriate rationales for sample size determination and statistical evaluation of the results.
  • Lead/support effective execution of CAPA program, reviewing adequacy/integrity of CAPA activities, participation in CAPA investigations, and checking for effectivity of CAPAs post-implementation.
  • Lead/support effective execution of the Supplier Management program, including facilitation of supplier assessments/qualifications, part/ process qualification, First Article assessment, supplier performance monitoring, supplier audits, and SCARs.
  • Lead/participate in internal audits of Hologic Newark based on ISO 13485:2016, QSR, other jurisdictional country specific standards and general cGMP in support of other Hologic site/ divisions. Develop audit plans, conduct quality audits, prepare audit reports and communicate findings, including compliance risk.
  • Review and evaluate internal audit responses against current industry standards, regulations and guidelines to assure compliance. Drive closure of corrective and preventative actions to ensure implementation, compliance and continuing efficacy.
  • Lead/support the collection, analysis, and communication of post-market Quality data to the Manager, Corporate QA and Senior QA Management, including complaints, reportable or adverse events, NCRs, and Supplier Performance.
  • Generate/revise QMS documents and facilitate their release through the Agile change process.
  • Participate in CCB approval process as QA representative.
  • Lead gap assessment audits and readiness inspections as needed.

Qualifications
Education          
  • B.S. degree in related discipline
  • Education/training in developing and maintaining compliant Quality Systems
 
Experience         
  • 5 years of experience developing, managing, executing, and improving Quality Management Systems in the medical device/pharmaceutical industry
  • Strong working knowledge of domestic and international regulations for medical device manufacturing and distribution
 
Skills
  • Strong knowledge of the regulation associated with the domestic manufacturing and distribution of medical devices (ISO 13485, 21 CFR 820, etc.)
  • Experience with the design, development, and implementation of compliant QMS documents (Standard Operation Procedures, Work Instructions, Forms, etc.)
  • Experience with the managing and execution of CAPAs and the CAPA system
  • Experienced with the administration of the Supplier Management process (qualification, control, audit scheduling, etc.)
  • Experience with managing and executing internal audits
  • Experience with trending, analyzing, and reporting Quality data
  • Working knowledge of MDD 93/42/EEC (EU), TGA 2002 (Australia), BGMP RDC 16 (Brazil), CMDR SOR-98-282 (Canada), MHLW Ministerial Ordinance No. 169 (Japan), etc.
  • Certified Lead/internal auditor to ISO 13485.
  • Experience managing, executing, and improving processes defined in the Quality Management System (Internal Audit, Supplier Management, CAPA, etc.)
  • Experience using Agile or equivalent
  • Experience with the use of common software and analysis tools (MS Word, Excel, Minitab, etc.)
  • Detail-oriented and collaborative mindset

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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