Staff Quality Engineer, DePuy Synthes
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. We are recruiting for the best talent for Staff Quality Engineer to join our DePuy Synthes Quality organization located in Palm Beach Gardens, Florida. The Staff Quality Engineer reports to Supply Chain Quality Director and provides overall quality assurance leadership of on-site manufacturing areas engaged in the production of Johnson and Johnson products. Ensures manufacturing areas are meeting good manufacturing practices, international organization for standardization and any other applicable standards. Prepares, conducts, monitors and reports on audits of all quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards.
Requirements
- A Bachelor’s degree is required
- A minimum of 6-8 years of relevant work experience is required
- Experience working in regulated industries
- This position will require relevant experience working in manufacturing/operations.
- In-depth knowledge of product/process Risk Management (MDSAP, MDD, MDR, FDA and ISO standards)
- Experience and a proven track record of implementing appropriate risk mitigation
- Strong communication, teamwork, problem solving and decision-making skills
- Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
- The ability to perform "hands on" troubleshooting and problem solving is required
- Strong mentoring, coaching and leadership skills are required
- Demonstrated project management and project leadership abilities are required
Nice To Haves
- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making
- Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred
Responsibilities
- Develops standard operating procedures, specifications, and provides technical transfer and validation support
- Minimizes sample and scrap waste, assesses reliability and risks based on validated data, identifies root causes of problems, and reduces or eliminates sources of variation
- Audits and approves manufacturing, quality, engineering and validation documents for conformance to business practices and departmental procedures
- Provides data and documentation in support of the development of validation strategies.
- Acts as liaison to the regulatory affairs department to perform initial regulatory review of all engineering changes and modifications to products
- Provides sampling plans and approves inspection methods for evaluation and testing of components and products
- Provides support and expertise in reliability planning and reliability growth demonstration during new product development
Benefits
- employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- 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 period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
