Product Quality Engineer 1

Are you passionate about ensuring the quality and reliability of life-saving medical devices At Hologic we are seeking a Product Quality Engineer 1 to provide engineering support for on-market medical devices. In this role youll lead complaint investigations perform root cause analyses and implement corrective and preventive actions to improve product quality and compliance. Collaborating with cross-functional teams youll drive process improvements assess risks and deliver impactful solutions that enhance patient safety and customer satisfaction. If youre a proactive problem-solver with a background in quality engineering we encourage you to apply and make a difference in healthcare innovation.

Knowledge:

Strong understanding of FDA Quality System Regulations including Design Control requirements ISO 13485 EU Medical Device Regulation ISO 14971 (Risk Management) GMP and GDP.
Familiarity with root cause analysis tools risk management principles and compliance frameworks.
Preferred knowledge of test method validation statistical methods design of experiments (DOE) and industry standards related to reliability sterilization packaging and biocompatibility.

Education

• Bachelors Degree in Engineering (Mechanical Electrical or Biomedical preferred)

Experience

• Bachelors degree required in either Mechanical Biomedical Biomechanical or Electrical Engineering with 0-2 years experience
  • Experience in an FDA regulated industry preferred
  • Experience in root cause analysis or product development/R&D is beneficial

Skills

• Familiarity with FDA Quality System Regulations especially Design Control requirements ISO 13485 EU Medical Device Regulation ISO 14970 Risk Management GMP and GDP
• Ability to effectively work on project teams including taking leadership role on critical tasks to assure appropriate and timely completion/resolution
• Ability to appropriately assess written product and project documentation as an advocate for compliance and ability to effectively communicate assessment
• Knowledge of root cause analysis tools and ability to effectively participate in root cause activities for complaint investigations NCs CAPAs etc.
• Good communication and presentation skills
• Preferred:
• Familiarity with test method validation root cause failure analysis statistical methods and design of experiment
  • Familiarity with Reliability Electrical Safety Sterilization Packaging and Biocompatibility standards and requirements.
• Working knowledge of verification and validation requirements for a regulated product
• Familiarity with requirements analysis including development of testable and measurable specifications

• Knowledge of risk based and statistical analysis concepts

  Behaviors
  Detail-oriented and compliance-focused ensuring adherence to regulatory standards and quality system requirements.
  Proactive and results-driven with a strong sense of ownership for deliverables and outcomes.
  Collaborative and team-oriented building productive relationships across functions to drive quality improvements.
  Customer-focused with a commitment to addressing field quality issues and ensuring timely resolution.
  Continuous improvement mindset driving process optimization and identifying opportunities to enhance product quality.

  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 $78000-$122100 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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