Principal Quality Engineer
About The Position
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 uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Requirements
- Bachelor's degree in Mechatronics Engineering, Manufacturing Engineering, or related field and 6 years of experience in the job offered or in a Principal Quality Engineer-related occupation.
Responsibilities
- Establish and maintain policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including FDA and all other applicable global regulatory requirements.
- Develop and establish effective quality control and associated risk management plans for products.
- Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, DOE) to promote risk reduction and control.
- Work with cross-functional groups in support of new product and process development projects.
- Participate in New Product and Processes Development and Introduction (NPD/NPI) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with company Quality System policies, procedures, standards (FDA, ISO 13485) and other worldwide regulatory agencies, and other applicable standards as pertain to medical devices.
- Support LCM activities (IQ/OQ/PQ) and product quality investigations.
- Serve as subject matter expert on all quality tools.
- Write, review, and/or approve process and product validation protocols and reports, equipment qualifications (IQ, OQ, PQ, TMV), and engineering change orders.
- Direct Failure Mode and Effects Analysis activities for both Design and Process FMEA's.
- Ensure that development activities follow design control requirements, product is tested per applicable standards, and product is properly transferred to manufacturing.
- Provide all planning necessary to ensure effective product acceptance, including but not limited to inspection instructions, equipment and gage requirements, and sampling plans.
- Participate in MRB review of nonconforming product, recommend disposition and corrective action, and initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.
- Participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
- Assist Regulatory Affairs in developing submissions for new devices as necessary.
- Make decisions independently on engineering problems and methods.
- Represent the organization in conferences to resolve important questions, and to plan and coordinate work, and represent Quality Engineering function during regulatory inspections.
- Recommend issue resolution to senior management for significant capability and compliance issues.
Benefits
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation – 120 hours per calendar year
- Sick time - 40 hours per calendar year (or 48 in Colorado, 56 in Washington)
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Medical, dental, vision and time off benefits
- Other benefits as provided for in the applicable Collective Bargaining Agreement.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
