Johnson & Johnson is currently seeking a Principal Quality Engineer to join our organization located in Plymouth, MN!
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 https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
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We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
The Principal Quality Engineer 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 pertains to medical devices. Support LCM activities (IQ/OQ/PQ) and product quality investigations. Will be considered a subject matter expert (SME) on all quality tools and will work on complex problems and projects. Will demonstrate strong leadership in driving program/projects and be resourceful and creative in developing approaches and solutions to problems. Shares technical expertise with others and develops entry level engineers.
Key Responsibilities:
- Primary responsibilities include working with other functional groups in support of new product and processes development projects.
- Develop and establish effective quality control and associated risk management plans, as well as the usage of statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, DOE) to promote risk reduction and control.
- Write, review and/or approve process and product validation protocols and reports, equipment qualifications (i.e. 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. This includes, but is 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 and Assist Regulatory Affairs in developing submissions for new devices as necessary
- Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work and expected to mentor, coach, or supervise QEs.
- Represent Quality Engineering function during regulatory inspections.
- Recommend issue resolution to senior management for significant capability and compliance issues.
- Plans, develops, coordinates, and directs one or more large important engineering project or a number of small projects with many complex features.
Qualifications
Education:
- A minimum of a Bachelor's degree (or equivalent) in Engineering or related technical/scientific field. Master's degree is preferred.
Experience and Skills:
Required:
- A minimum of six (6) years of related work experience, in a medical device, pharmaceutical and/or a regulated industry.
- Ability to define problems, collect and analyze data, establish facts and draw conclusions and recommendations.
- Ability to use broad knowledge of regulatory, technical, and business requirements to conduct due diligence assessments.
- Ability to apply project management skills to ensure fulfillment of new product development requirements.
- Ability to develop and implement Quality standards.
- In-depth knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices.
- Demonstrated auditing and problem-solving skills.
- In-depth knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies.
- In-depth understanding of Six Sigma and Process Excellence tools and methodologies.
- Lean manufacturing experience desirable.
- Ability to effectively communicate with internal and external personnel at all levels of the organization.
- Well-developed influencing and negotiation skills. Ability to effectively train and mentor a diverse array of employees at all levels of the organization.
- Business and financial acumen.
- Must demonstrate a clear understanding of theoretical and practical fundamentals and experimental engineering techniques.
Other:
- Ability to proficiently communicate both verbal and written in English.
- This position will require to report to work onsite at Plymouth, MN Johnson & Johnson location.
- This position may require a 10% to 20% of domestic and/or international travel.
The anticipated base pay range for this position is $100,000 to $172,500.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. 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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.