What are the responsibilities and job description for the Quality Engineer 2 position at Hologic Careers?
Our PURPOSE—to enable healthier lives everywhere, every day—is driven by a PASSION to become global champions for women’s health. We succeed by fulfilling our PROMISE to bring The Science of Sure® to life through product quality, clinical differentiation, customer relationships and our team’s talent and engagement.
The Quality Engineer will provide quality support for new product development activities of medical device products following design control requirements and internal procedures. In addition to general engineering services and support for product manufacturing, quality control and new product development. This position is provided direction from the Manager to maintain the complaint and investigation processes and is capable of performing most activities with limited supervision.
Essential Duties and Responsibilities
- Compiles and analyzes quality system metrics (e.g., management review, compliance metrics, post market quality assurance) 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: Risk Management Plans, FMEAs, Risk Control, etc. for new and released products.
- Remediation of product documentation for changes in product compliance for new or updated regulations (i.e., MDR, IVDR)
- 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 preventive actions
- Lead projects related to NPI and Transfers
- 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)
Education
- Bachelor’s degree in related discipline. Relevant work experience may offset the educational requirement.
Experience
- 2-3 years of experience as a Quality Professional in the Medical Device industry required.
Skills
- Knowledge of ISO 13485 is essential as well as FDA and cGMP regulations and documentation practices
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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