Job Description
Role: NPD Quality Engineer
Location: Plymouth, MN (Onsite)
Job Type: Full Time
Job Description
Must Have Technical/Functional Skills
• Knowledge on Quality Management and its tools & techniques
• Knowledge about GMP (Good Manufacturing Practices), FDA, ISO 13485 and compliance regulations
• Knowledge on Medical Device Regulatory Standards, MDD and MDR
• Knowledge on NC, CAPA, Root Cause Analysis and Audit processes
• Knowledge on Validation process, writing protocols/ reports
• Very good understanding/ experience in writing procedures, product specs and work instructions
• Knowledge in Statistics, Risk Management and Design control
• Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills
• Experience in creating FMEAs & Writing reports
• Experience in PMS (Post Market Surveillance)
• Experience in PLM Tool (Windchill)
• Good understanding of Design, Drawing and GD&T
• Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred
• Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software
• Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)
Roles & Responsibilities
• Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are:
• Development and review of PDP (Product development Process) deliverables
• Review and approve R&D/ Engineering protocol/ reports
• Development of Risk management records (i.e. DFMEA/ PFMEA) in collaboration with SMEs
• Support and provide guidance on Validations and if required write Validation Protocols/ Reports
• Support/ Remediation of Validation/ Quality Documentation
• Support Root Cause Investigation and closure of NC and CAPA
• Review and approve the Change Orders (CR/ CN)
• Review and update the design/ process control documents like procedures/ work instructions/ product specs etc.
• Work with cross functional teams and internal teams to create deliverables
• Performs other duties assigned as needed
Salary Range: $90,000 $95,000 Year
TCS Employee Benefits Summary:
Discretionary Annual Incentive.
Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
Family Support: Maternal & Parental Leaves.
Insurance Options: Auto & Home Insurance, Identity Theft Protection.
Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
Time Off: Vacation, Time Off, Sick Leave & Holidays.
Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.