Johnson & Johnson Careers
Staff Supplier Quality Engineer
Requisition ID: 1805682875W
Mentor Medical Systems is part of the Johnson & Johnson family of companies.
Mentor is a trusted global leader in aesthetic medicine among both consumers and clinicians by providing a broad range of innovative, science and clinical-based solutions to maintain, enhance, and restore self-esteem and quality of life. The company has products and services in three areas of aesthetics: breast (augmentation and reconstruction), body and face.
Currently we are looking for:
STAFF SUPPLIER QUALITY ENGINEER
Participate, support, and lead activities related to suppliers of raw material, components, finished devices and services for the inspection of incoming materials, implementation of corrective/preventive actions, validations, certifications, qualifications and any project related to quality improvement.
This position has responsibilities on Ethicon and Cardiovascular and Specialty Solution (CSS) Family of Johnson and Johnson companies, including multiple product platforms such as General Surgery Medical Devices, Sutures, ENT, Infection Prevention, Electrophysiology and Esthetic Surgical and non-surgical devices.
DUTIES & RESPONSIBILITIES
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Supports different business units on the company, following up on situations related to supplier quality.
- Support the incoming inspection group (technician, team lead, supervisor, etc) on the decision-making process and follow up of material nonconformance with suppliers.
- Responsible to coordinate supplier investigations, related to material non-conformances.
- Participate in the investigation process and risk analysis of non-conformances caused by suppliers.
- Works directly with suppliers and external manufacturers to ensure the products and services received meet requirements and/or specifications.
- Responsible for approving and/or escalating deviations on product specifications or processes from supplier
- Visit and evaluate suppliers thru audits or technical assessments.
- Develop and implement improvement programs for suppliers.
- Support the Quality Audit group providing quality metrics and supplier performance data.
- Participate and support the introduction of new products in relation to new components or finished devices provided by suppliers.
- Supports the qualification, validation and certification of supplier’s inspections methods and equipment.
- Responsible for the generation or updates to Supplier Quality Agreements.
- Participate with other functional groups and support activities related to changes requested by or to suppliers.
- Responsible to review, create and approve changes to company procedures, work instructions, forms, inspection reports and other related controlled documentation.
- Complete all training on time assigned by the quality compliance department.
- Responsible for follow ups, implementation and closure of company corrective and preventive actions either internal or external.
- Attend and participate in quality metric reviews.
- Participate in different projects like Kaizen, PE (GB/BB) and lean.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. This includes but not limited to all applicable regulations and standards for maintaining the quality management system, such as 21CFR Part 820 and ISO 13485.
- Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing
EXPERIENCE AND EDUCATION
- Bachelor degree in an engineering discipline is required.
- Professional experience of 5+ years in a related industry are required.
- 5+ yeas of experience in Quality Assurance working with suppliers is required.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
- Strong knowledge on corrective and preventive action systems (CAPA).
- Basic knowledge on statistical analysis and problem-solving techniques.
- Basic knowledge of project management tools. Experience implementing tools in desired.
- Strong understanding of GMP, QSR, ISO 13485 requirements.
- Experienced with validation, certification and auditing of suppliers.
- Understands specification drawings and departmental procedures.
- Knowledge of document control systems, preferably ADAPTIV and JDE.
- Understands six sigma tools, preferably Green Belt certified or higher.
- Works under minimum supervision and takes self-directed action.
- Ability to negotiate and mentor other engineers.
- Ability to take actions as needed based on J&J Credo.
- Ability to develop and implement quality standards.
- Understands business principles.
- Effective verbal and written communication skills.
- Proficient at speaking, writing and understanding English.
- ASQ (or other) certified in Quality Engineering and/or Quality Auditor is desired.
- Green Belt or higher certification is preferred.
ADDITIONAL POSITION REQUIREMENTS
- Able to travel.
- Able to work extra time based on requirements.
RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
- This position reports to Supplier Quality Manager (or Director of Supplier Quality).
- When acting as Team Leader, this position is responsible to supervise other Supplier Quality Engineers in its organization
- Acting as the primary contact of supplier quality department at its location
- Works with Sourcing, Purchasing, R&D, LCM, Quality Assurance and Engineering ensuring that Purchasing Controls are effectively implemented.
- Participates in company internal and external audits.
- Hosts or supports business meetings with suppliers and other functions
- Participates in Data Review Boards and Management Reviews
Mentor Medical Systems, B.V. (8808)