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Product Quality Engineer 1

Hologic Careers
Newark, USA
Full-time
Entry · 0–2 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 0-2 years experience
  • Experience in root cause analysis or product development/R&D is beneficial
  • 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
  • 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
  • Why Hologic?
  • We are committed to making Hologic the company where top talent comes to grow. 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.
  • If you have the right skills and experience, apply today!
  • 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.

Experience

  • Experience in an FDA regulated industry preferred

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
  • The annualized base salary range for this role is $54,900 - 86,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.
  • Why Hologic?
  • We are committed to making Hologic the company where top talent comes to grow. 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.
  • If you have the right skills and experience, apply today!
  • #LI-AV1
  • 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.

Preferred Qualifications

  • Bachelor’s Degree in Engineering (Mechanical, Electrical or Biomedical preferred)
  • Experience in an FDA regulated industry preferred
  • The annualized base salary range for this role is $54,900 - 86,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.

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