Job Title – Sr. Quality Engineer [Must Have Design Control]

Location – Andover, MA

Duration – 12+ Months Contract

Total Hours/week - 40.00
1st Shift

Description:
Shift hours: First shift, flexible with reason
Site Location Address: 200 Bulfinch Dr, Andover, MA 01810

Interviews – phone, video or in person: Can be video or in person as appropriate

3 must haves on the resume:
1. Design Control
2. Risk Management
3. Medical Device Exp.

Senior Quality Engineer --- Summary Job Description:
This position is accountable for supporting new product development for complex electromechanical medical devices. This person will support risk management and design control activities from product inception through product launch while ensuring products meet regulatory requirements, quality standards consistent with company policies.

Responsibilities:
• Lead Risk Management activities (RMP, HA, DFMEA, PFMEA, UFMEA and RMR).
• Support safety assurance case creation in compliance with the regulatory requirements.
• Review, and approve design control deliverables such as requirements, specifications, validation protocols and reports to ensure compliance to customer and regulatory requirements.
• Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements
• Provides guidance to cross-functional development team(s) in approach to design control documentation.
• Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps
• Support design test and inspection method development, and lead method validation activities
• Responsible for establishing, communicating, and mitigating risk throughout the product development process
• Participate in design reviews
• Performs other related duties and responsibilities, on occasion, as assigned

Experience and Education:
• B.S. degree, in a scientific, technical, or engineering discipline.
• 5+ Years of experience in design controls and risk management
• Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485 and ISO 14971
• Must possess excellent oral and written communication skills, and and the ability to communicate appropriately with cross functional teams
• Demonstrated ability to understand and communicate complex technical, statistical and compliance subject matter
• Ability to manage and prioritize multiple activities with varying business, compliance and customer drivers.
• Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines. Will be working on highly visible projects in high-pressure situations