Quality Assurance Engineer 2

Join Hologic as a Quality Engineer in a regulated medical device environment responsible for ensuring products processes and systems meet internal quality requirements and external regulatory standards (e.g. FDA ISO). The position supports Operations Engineering and R&D focusing on defect prevention continuous improvement and robust manufacturing practices.

Knowledge

• Quality Management Systems (QMS) for medical devices
• GMP GDP principles and basic regulatory frameworks
• Medical device Quality System Regulations (21 CFR 820) ISO 13485 MDD (beneficial)
• Risk management risk assessments and documentation updates
• Nonconformance (NCE) CAPA SCAR MRB processes
• Inspection testing and validation methods for products and processes
• Statistical analysis and scientific method (beneficial)
• Basic understanding of microbiology molecular biology biochemistry chemistry or related fields (beneficial)
• Nucleic acid amplification and detection technologies (beneficial)
• Company quality system requirements and standards

Skills

• Strong computer literacy: word processing spreadsheets databases
• Ability to develop and implement procedures inspection procedures and test methods
• Excellent technical writing; able to produce clear quality reports and detailed procedures
• Ability to read analyze and interpret technical procedures standards journals and regulations
• Effective presentation and communication skills
• Good interpersonal skills; able to work with all levels including in potentially adversarial situations
• Familiarity with Oracle and Agile systems (beneficial)
• Certified Quality Engineer (beneficial)

Behaviors

• Models and champions quality values and best practices
• Acts with urgency in identifying and resolving quality issues
• Uses sound judgment within defined procedures and practices
• Focuses on defect prevention reduction of variation and waste and continuous improvement
• Maintains productive internal and external working relationships
• Stays current with industry and technical developments through literature review
• Works independently on routine tasks seeking guidance for new or complex assignments
• Engages proactively in cross-functional forums (MRB NCE CAPA SCAR) and regulatory interactions

Experience

• 25 years with Bachelors degree; 12 years with Bachelors in a technical field; 02 years with a Masters degree
• Working in regulated environments ideally FDAregulated or medical devices (beneficial)
• Supporting Operations Engineering and R&D in product and process development
• Participating in audits and inspections (facility supplier Notified Body FDA)
• Handling nonconformances complaints root cause analysis and corrective actions
• Reviewing and approving ECOs product changes verification/validation and sustaining engineering documentation

Why join Hologic

We are committed to making Hologic the destination for top talent. For you to succeed we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $97600-$152700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience skillset knowledge education business needs and market demand.

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 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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