Johnson & Johnson Careers
Compliance Engineer (m/f/d) initially limited to 18 months
Requisition ID: 1905715119W
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Under the direction of the Compliance Manager, and with the objective of maintaining high Quality standards for product manufacturing processes and compliance with all applicable regulatory requirements, the Compliance Engineer ensures the appropriate execution and where applicable improvement of the Quality Management System.
- Support the preparation and execution activities for all External Audits, Audit Follow ups, and perform post-Audit activities
- Execute the Internal Audit program against established internal audit procedures
- Provide support for JJRC audits as requested
- Support ensuring site is audit ready, especially focus on unannounced audit readiness plans
- Completion of sites audit readiness tools and coordination of Dynamic Audit Readiness Activities Provide input into the Quality & Compliance metrics to ensure these are consistently and accurately captured, and that metrics are captured at the appropriate level for subsequent analysis and reporting (e.g., site level, supply chain)
- Escalate compliance items in accordance with established procedures
- Support implementation of new external standards/regulations for Supply Chain Sites
- Provide data for input into Site Management Reviews (e.g., internal audits.) to allow meaningful review
- Apply Credo values in an open and ethical manner and promote Credo values within the Compliance and site teams.
We believe we can make a difference and we take your career seriously and your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth. If you enjoy solving hard problems, you're a self-starter and you're passionate about your career every single day, we'd love to hear from you!
- A Bachelor's degree in engineering, scientific, technical scientific, or Quality Regulatory Compliance disciplines is required
- Minimum of 1 year of regulated healthcare industry experience in, operations, regulatory and/or quality compliance is required
- Prior experience in an and experience working with an indirect organization that delivers results is required
- Understands the linkages in quality and regulatory compliance from product development through manufacturing and delivery to customer and health authority is required
- Builds consensus, can lead individuals through change and has strong project management experience
- Ability to assess risk when dealing with multiple priorities
- Lead auditor training is preferred
- Six Sigma, Lean, 5S or ASQ Certification and trainings is preferred
- Must have excellent communication skills, and strong collaboration and influence skills to partner effectively across functions and operating units is preferred
- Ability to coach and support individuals to develop compliance mindset, including conducting robust failure investigations, creating action plans and verifying their effectiveness
- Strong knowledge of FDA 21 CFR Part 210, 211 and 820 and ISO 13485 and SAP, ERP systems are preferred
Johnson & Johnson is an equal opportunity employer. We value diversity at our company. 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.
Johnson&Johnson Med GmbH (7930)