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Skillman, NJ, US

Principal Supplier Quality Engineer-1672121205

Description

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. is currently recruiting for a Principal Supplier Quality Engineer located in Skillman, NJ.

Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. develops and markets baby care, wound care and skin care products that address the needs of consumers and health care professionals and incorporate the latest innovations. The portfolio includes heritage brands JOHNSON'S® Baby and BAND-AID® Brand, as well as leading skin care brands such as AVEENO® and CLEAN & CLEAR®.

The Principal Supplier Quality Engineer will be part of the J&J North America Supplier Quality Management group. This group is responsible for qualifying and supporting suppliers for materials used in J&J consumer products including OTC and medical device products. The team is located at multiple J&J campuses in North America. North America Supplier Quality Management develops, implements, and ensures compliance to supplier and material guidelines and policies. This position will be responsible for creating, revising, implementing, and providing training on Supplier Quality policies.

The Principal Quality Engineer (QE) will act as the quality subject matter expert on cross-functional project teams to determine and conduct activities to qualify new suppliers. These activities include assessing quality system information for new suppliers through questionnaire review and GMP auditing, assessing and tracking supplier action plans, negotiating Quality Responsibility Agreements with suppliers to ensure expectations are mutually understood and agreed upon, and reviewing and approving material specifications.

This position will also support maintenance of existing supply base through review and approval of change control documentation and material specification revisions, periodic supplier quality system assessment, Quality Responsibility Agreement negotiation, and participation in supplier nonconformance investigations. The Quality Engineer will identify, elevate, and recommend solutions for material or supplier risks.

Qualifications


A Bachelor of Science degree plus a minimum of 8 years of relevant work experience in the Pharmaceutical, OTC or other highly regulated industry is required. A focused degree in Chemistry, Engineering, Microbiology, Biology or another closely related technical discipline is preferred. Knowledge of the principles and practices of Quality Assurance in the consumer, pharmaceutical, or medical device industry is required. Knowledge of GMP requirements and current FDA enforcement regulations is required. Previous supplier quality experience is preferred. Quality auditing experience is required. Expertise with root cause analysis techniques including but not limited to: Brainstorming, data analysis and collection tools, 5 Whys, Fishbone (Cause and Effect), FMEA, and DMAIC is required.

Experience with systems and tools supporting analysis and reporting is required. Excellent communications (verbal, written and listening) and collaboration skills - demonstrated through work products, presentations, accurate information gathering, and productive discussions/results are required. Strong knowledge of GMP Regulations, quality system guidelines including but not limited to: CFR parts 11, 210, 211, 820, and 803, ICH Q7, Q8 and Q9, ISO 10002, 9001, 13485, and 14971, IPEC, and EFfCI is preferred. The candidate is preferred to have experience implementing quality system improvements, alerting organization to issues in time to resolve potential adverse effects, and leading quality initiatives. Project management and regulatory authority interaction is a plus.

Strong influence and negotiation skills and leading without direct line authority experience are required. The ability to manage complexity and lead a diverse team is critical. It is required that this candidate be able to deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches. Experience influencing and impacting others, and reaching consensus of opinion through building, defending and/or challenging in a provocative and respectful manner is required. This position will be based in Skillman, NJ and may require up to 20% domestic and international travel.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Skillman
Organization: Johnson & Johnson Consumer Inc. (6071)