At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are positioned to innovate across the full spectrum of healthcare solutions today to deliver breakthroughs of tomorrow.
SECTION 1: JOB SUMMARY
The Staff Supplier Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites and raw material suppliers engaged in the production of Johnson & Johnson products.
The Staff Supplier Quality Engineer maintains the qualification of suppliers and their processes, leads activities to resolve complex technical issues that may require development of new or improved techniques or procedures, and provides technical leadership and project management to qualify and improve supplier processes for the manufacture of medical devices.
SECTION 2: DUTIES & RESPONSIBILITIES
Support Quality Systems including change control, supplier non-conformances, ASL management, Quality Agreements and department procedures and system requirements.
Perform and support supplier/EM quality evaluations and/or audits, development of quality agreements, and other quality-related activities impacting suppliers.
Lead activities to resolve supplier quality issues, including root cause analyses, corrective actions, and monitoring effectiveness.
Lead supplier risk management activities, identify high-risk areas, establish and monitor risk mitigation plans, participate in risk management projects, and communicate risks to management.
Lead supplier process improvement efforts, identify sources of variation, implement process controls, and drive best practices adoption.
Provide Quality Engineering support to suppliers including assessments, inspection technique support, verification/validation activities, CAPA and change management, with focus on FDA CFR Part 820 and ISO 13485 regulations/standards.
Ensure compliance with validation regulations and standards (e.g., QSRs, ISO, EN, MDD/MDR) and support internal and external audits.
Apply industry and process excellence standards in daily quality operations, including GMP, EES, and ISO.
Develop and report supplier performance metrics and participate in local site supplier quality meetings.
Communicate business-related issues or opportunities to management.
If supervising staff, ensure compliance with Health, Safety and Environmental practices and provide needed resources.
Ensure personal and Company compliance with all applicable regulations, policies, and procedures.
Perform other duties as needed.
SECTION 3: EXPERIENCE AND EDUCATION
Bachelor's Degree required; Master's Degree preferred.
Generally requires 4–6 years of experience in a GMP and/or ISO regulated industry.
Experience in the medical device / pharmaceutical industry is preferred.
Engineering or science field of study is preferred.
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS
Excellent communication, teamwork, and problem-solving skills.
Expertise in quality event investigations including root cause analysis and corrective actions.
Experience with machining, injection molding, metal processing (passivation, anodizing, heat treating) and/or electronics assembly is preferred.
Knowledge of FDA CFR and ISO regulations; FDA CFR Part 820 and ISO 13485 knowledge preferred.
Auditing background is a plus.
Six Sigma, Lean, ASQ certifications and professional licenses are preferred.
Strong statistical analysis skills.
Fluency in English required.
#J-18808-Ljbffr