Hologic Quality Engineer in Marlborough, Massachusetts

Quality Engineer

Post Date Nov 27, 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 support for new product development activities of medical device products following design control requirements and internal procedures. Provides general engineering services and support for product manufacturing, quality control and new product development.

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.

  • Compiles and analyzes quality system metrics (e.g. management review, compliance metrics, post market quality assurance, etc.) in order to ensure key process indicators are identified, measured and action driven. Identifies unacceptable trends and drives suitable corrective action

  • Facilitate and actively contribute to the risk management activities per ISO 14971:2012: Risk Management Plans, FMEA’s, Risk Control, etc. for new and released products.

  • Supports Materials nonconformance investigation, disposition and release activity as applicable

  • Creating appropriate harm/hazard analysis/health hazard assessment for issues potentially impacting patient outcomes

  • Investigate, identify and implement corrective and or preventive actions to close CAPAs

  • Lead projects related to NPI and Transfers

  • Prepare technical product documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders (ECO), etc.

  • Work with manufacturing engineer/process engineer to ensure necessary process controls are in place

  • Write, review and/or approve reports for: test method validations, design verification, design validation, and process validations (IQ, OQ, PQ).

  • Participate in supplier quality management assessment and qualification as required.

  • Lead or participate in product, component or assembly qualifications at suppliers.

  • Write, review and / or approved quality plans to support product activities both internal and external.

  • Participate in project teams and company initiatives to assure compliance with Quality System requirements while achieving company objectives.

  • Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE)

Qualifications

Education

  • Bachelor’s degree in related discipline. Relevant work experience may offset the educational requirement.

  • Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) certificates from American Society for Quality (ASQ) are a plus

Experience

  • 5+ years of experience as a Quality Professional in the Medical Device industry required.

Skills

  • Knowledge of ISO 13485:2016 and MDSAP is essential as well as FDA and cGMP regulations and documentation practices

  • Strong understanding of Remediation activities for QMS & Process

  • Knowledge of new EU regulations (MDR / IVDR) and implementation of those regulations preferred

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.