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Supplier Quality Engineer III

Auris Health

Auris Health

Quality Assurance
United States
Posted on Thursday, August 3, 2023
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Description

DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a Supplier Quality Engineer III to be located in Palm Beach Gardens, Florida.

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

The Supplier Quality Engineer III provides overall quality assurance leadership in the management of select contract manufacturing sites and raw material suppliers engaged in the production of Johnson and Johnson products.

Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!

Key Responsibilities:

  • Supports audits to good manufacturing practices, international organization for standardization and any other applicable standards.
  • Provides product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
  • Apply varied industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
  • Address product and process complaints accordingly.
  • Build reports on contract manufacturer performance metrics and management reviews.
  • Ensure comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management.
  • Handle technical issues for manufacturing processes that are to be transferred to satellite facilities.
  • Provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and organizational change.
  • FDA CFR Part 820 and ISO 13485 regulations/standards will be the focus.

Qualifications

Education:

  • A minimum of a bachelor’s degree is required. Degree in Engineering, Life Science, or related field is preferred.

Experience and Skills:

Required:

  • A minimum of 4 years of work experience in a GMP and/or ISO regulated industry
  • Strong communication, teamwork, and problem solving skills
  • Strong root cause analysis skills

Preferred:

  • Experience in the medical device and/or pharmaceutical industry
  • FDA and ISO regulations knowledge
  • Experience in robotics, electronics and/or software
  • Operations supplier quality experience
  • FDA CFR Part 820 and/or ISO 13485 knowledge
  • Auditing background
  • Experience or knowledge with machining manufacturing processes and injection molding
  • Six Sigma, Lean, or ASQ Certification and trainings

Other:

  • This position may required up to a 10% of domestic and/or international travel.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.