NPD Quality Engineer

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.

Location

Plymouth, MN

Job Function

TECHNOLOGY

Role

Engineer

Job Id

Desired Skills

Quality Management | PLM | Windchill

Salary Range

$90,000-$95,000 a year

Desired Candidate Profile

Qualifications : BACHELOR OF COMPUTER SCIENCE