Hologic Senior Quality Assurance Engineer in Newark, Delaware

Senior Quality Assurance Engineer

Post Date Oct 09, 2018

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 theimplementation, 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 tothe compilation, analysis, and presentation of post-market Quality data,including Management Review, Risk Management Board, Complaint Review, NCRreviews, and Supplier Performance reviews.

Essential Duties and Responsibilities

The incumbent may beasked to perform other function-related activities in addition to the belowmentioned responsibilities as reasonably required by business needs.

  • Lead/ support manufacturing for all process changes,assuring appropriate rationales for sample size determination and statisticalevaluation of the results.

  • Lead/support effective execution of CAPA program,reviewing adequacy/integrity of CAPA activities, participation in CAPAinvestigations, and checking for effectivity of CAPAs post-implementation.

  • Lead/support effective execution of the SupplierManagement program, including facilitation of supplierassessments/qualifications, part/ process qualification, First Articleassessment, supplier performance monitoring, supplier audits, and SCARs.

  • Lead/participate in internal audits of Hologic Newarkbased on ISO 13485:2016, QSR, other jurisdictional country specific standardsand general cGMP in support of other Hologic site/ divisions. Develop auditplans, conduct quality audits, prepare audit reports and communicate findings,including compliance risk.

  • Review and evaluate internal audit responses againstcurrent 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, andcommunication of post-market Quality data to the Manager, Corporate QA andSenior QA Management, including complaints, reportable or adverse events, NCRs,and Supplier Performance.

  • Generate/revise QMS documents and facilitate theirrelease through the Agile change process.

  • Participate in CCB approval process as QArepresentative.

  • Lead gap assessment audits and readiness inspectionsas needed.

Qualifications

Education

  • B.S. degree in related discipline

  • Education/training in developing and maintainingcompliant Quality Systems

Experience

  • 5 years of experience developing, managing,executing, and improving Quality Management Systems in the medicaldevice/pharmaceutical industry

  • Strong working knowledge of domestic andinternational regulations for medical device manufacturing and distribution

Skills

  • Strong knowledge of the regulation associated withthe domestic manufacturing and distribution of medical devices (ISO 13485, 21CFR 820, etc.)

  • Experience with the design, development, and implementationof compliant QMS documents (Standard Operation Procedures, Work Instructions,Forms, etc.)

  • Experience with the managing and execution of CAPAsand the CAPA system

  • Experienced with the administration of the SupplierManagement process (qualification, control, audit scheduling, etc.)

  • Experience with managing and executing internalaudits

  • Experience with trending, analyzing, and reportingQuality data

  • Working knowledge of MDD 93/42/EEC (EU), TGA 2002(Australia), BGMP RDC 16 (Brazil), CMDR SOR-98-282 (Canada), MHLW MinisterialOrdinance No. 169 (Japan), etc.

  • Certified Lead/internal auditor to ISO 13485.

  • Experience managing, executing, and improvingprocesses defined in the Quality Management System (Internal Audit, SupplierManagement, CAPA, etc.)

  • Experience using Agile or equivalent

  • Experience with the use of common software andanalysis tools (MS Word, Excel, Minitab, etc.)

  • Detail-oriented and collaborative mindset

Agency and Third PartyRecruiter 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 Employerinclusive of disability and veterans.