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Lead Product Quality Engineer

Hologic Careers
Newark, USA
Full-time
Lead · 8+ years experience
Onsite
Discovered 3 weeks ago

Full Job Posting

Qualifications

  • Education
  • Bachelor’s Degree in Engineering (Mechanical, Electrical or Biomedical preferred)
  • Bachelor's degree required in either Mechanical, Biomedical, Biomechanical, or Electrical Engineering with 8+ years’ experience, 6+ years with master’s degree, 3+ Years with PhD.
  • Experience in an FDA regulated industry
  • Demonstrated experience leading root cause analysis and complex complaint investigations; experience in product development/R&D is beneficial
  • Demonstrated experience coaching, mentoring, or training engineers or technical staff
  • In-depth knowledge of FDA Quality Management System Regulation (21 CFR 820), especially Design Control requirements, ISO 13485, EU Medical Device Regulation (EU MDR 2017/745), ISO 14971 Risk Management, GMP, and GDP
  • Proven ability to lead 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
  • Strong knowledge of root cause analysis tools and ability to lead, and coach others in, root cause activities for complaint investigations, NCs, CAPAs, etc.
  • Excellent communication and presentation skills, including the ability to influence cross-functional partners
  • Strong coaching and mentoring skills, with the ability to develop technical capability in others
  • Ability to develop and maintain product knowledge; serving as the subject matter expert for assigned product lines
  • Ability to manage multiple projects and priorities at one time
  • Works with high degree of autonomy and independence, requiring minimal oversight on highly complex problems with analysis requiring a variety of factors.
  • 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
  • ASQ Certified Quality Engineer (CQE) or equivalent
  • 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.
  • 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 is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.

Skills

  • In-depth knowledge of FDA Quality Management System Regulation (21 CFR 820), especially Design Control requirements, ISO 13485, EU Medical Device Regulation (EU MDR 2017/745), ISO 14971 Risk Management, GMP, and GDP
  • Proven ability to lead 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
  • Strong knowledge of root cause analysis tools and ability to lead, and coach others in, root cause activities for complaint investigations, NCs, CAPAs, etc.
  • Excellent communication and presentation skills, including the ability to influence cross-functional partners
  • Strong coaching and mentoring skills, with the ability to develop technical capability in others
  • Ability to develop and maintain product knowledge; serving as the subject matter expert for assigned product lines
  • Ability to manage multiple projects and priorities at one time
  • Works with high degree of autonomy and independence, requiring minimal oversight on highly complex problems with analysis requiring a variety of factors.
  • 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
  • ASQ Certified Quality Engineer (CQE) or equivalent
  • 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 $119,300 - $186,600 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 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.
  • #LI-AV1
  • Hologic is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.

Preferred Qualifications

  • Bachelor’s Degree in Engineering (Mechanical, Electrical or Biomedical preferred)
  • The annualized base salary range for this role is $119,300 - $186,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

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