What are the responsibilities and job description for the Sr. Development Quality Engineer (Medical Devices) position at TekOne IT Services Pvt. Ltd.?
Role: Sr. Development Quality Engineer (Medical Devices)
Location: St. Paul, MN - 55117
Duration: 12 Months on W2Contract
Shift Timings: 8:30 AM to 5 PM
Required Qualifications
Location: St. Paul, MN - 55117
Duration: 12 Months on W2Contract
Shift Timings: 8:30 AM to 5 PM
Required Qualifications
- Bachelor’s degree within an Engineering field or a closely related discipline.
- 5-8 years of Medical Device engineering experience and demonstrated use of Quality tools/methodologies – Development Quality experience highly preferred
- Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.
- Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
- Lead on-time completion of projects supporting quality and business initiatives.
- Support the definition of objective, measurable, discrete, and verifiable customer requirements, external requirements, and product requirements.
- Lead Risk Management activities including analyzing field data to update Risk Management
- File documents such as, Failure Modes and Effects Analysis (FMEA), Hazard Analysis, and Risk Management Plan/Report.
- Support Test and Inspection Method development including Method Validation activities.
- Accountable for Design Verification and Design Validation planning and execution, including cross-functional root-cause investigation and resolution activities.
- Support manufacturing process development and qualification for design changes.
- Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identifying, communicating, and resolving gaps.
- Lead and support Corrective Action Preventive Actions (CAPAs) in a timely and objective manner.
- Lead, coach, and mentor junior engineers.
- Build strong collaborative partnerships with cross functional teams including Program
- Management, Research & Development, Regulatory, and Process Development to ensure cross functional customer needs are met without creating barriers to development cost, time, and scope.
- Support preparing Regulatory Submission documentation and responding to questions from Regulatory Agencies.
- Additional duties may be identified by functional management based on current project/business objectives.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.