Engineer, Quality in Maplewood, MN at Volt

Date Posted: 11/25/2019

Job Snapshot

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