Quality Engineer II in Maplewood, MN at Volt

Date Posted: 1/9/2020

Job Snapshot

Job Description

Development Quality Engineer II (10-month contract)

St. Paul, MN

We are seeking an experienced, high caliber Development Quality Engineer II to assure that new or modified products conform to quality standards and establish compliance with the quality system.  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. Each employee can make a difference and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
 - 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 Design Control Deliverables
- Support on-time execution of  Quality Plans for internal product development process (PDP), OEM-based, Clinical Product Development (CPDP), and design change projects
- Accountable for generation of PDP design verification test plans/reports for product/system requirements
- Lead or support Risk Management activities from product Concept through Commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, FMECA’s and Cybersecurity risk assessments
- Lead identification of essential outputs and generate Essential Output reports
- Accountable for completion of labeling verification activities and labeling verification reports
- Work with design engineering in the completion of customer/system/product requirements
- Work with design engineering in the completion of product verification and validation
- Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
- Complete Document Change Request Reviews in a timely and objective manner
- Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
- Assist in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
- Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Additional duties may be identified by functional management based on the current project/business objectives
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
- 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

- 2-5 years’ experience
- Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
- Working knowledge of FDA 21 CFR Part 820, GMP, and ISO 13485
- Experience supporting product design and development
- 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 statistical/data analysis and report writing skills
- Ability to work in a highly matrixed and geographically diverse business environment
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Ability to leverage and/or engage others to accomplish projects
- Multitasks, prioritizes and meets deadlines in timely manner
- Strong organizational and follow-up skills, as well as attention to detail
- Ability to travel approximately 10%, including internationally

Your preferred qualifications and education:

- Prior medical device experience preferred
- Experience working in a broader enterprise/cross-division business unit model preferred

Volt is an Equal Opportunity Employer