Engineer, Quality in Maplewood, MN at Volt

Job Description

Development Quality Engineer (12-month contract)

St. Paul, MN

Job Description

Volt is seeking a high caliber Development Quality Engineer! A development quality engineer assures new or modified products conform to requirements and establishes compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Responsibilities

• Execute on-time completion of design control deliverables
• Design verification and validation test planning
• Writing design verification and validation test protocols, execution and reports
• Design input output trace matrix
• Design History File organization
• Customer, system, and product requirement review
• Regulatory responses and submissions
• Risk/hazard analysis and risk management plan/reports
• Design specification reviews
• Quality plans
• Design change plan/reports
• Investigate internal and external audit findings and write responses
• Corrective and preventive action resolution
• Complete document change requests
• Ability to work independently with minimal/no supervision
• Maintain high standards for content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating & resolving gaps
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments
• Maintain 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
• Perform other duties and responsibilities as assigned by functional management based on the current project/business objectives including regular predictable attendance

Requirements:

• 0-2 years’ experience in medical device R&D or Quality role
• Bachelor level degree in an Engineering Discipline or other Technical Field
• Solid communication and interpersonal skills
• Strong verbal communications and written communications with ability to effectively communicate at multiple levels in the Organization
• Advanced computer skills, including very strong report writing skills and document control database navigation and use
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Self-directed: Multitasks, prioritizes and meets deadlines in timely manner with minimal oversight
• Strong organizational and follow-up skills, as well as attention to detail

Preferred qualifications and education:

• Degree in Mechanical, or Biomedical Engineering
• 2-4 years previous medical device Quality engineering experience and demonstrated use of Quality tools/methodologies
• Working knowledge of FDA 21 CFR Part 820, GMP, and ISO 13485

Volt is an Equal Opportunity Employer