Development Quality Engineer - The Fountain Group

St. Paul, MN

About the Job

The Fountain Group is currently seeking a Development Quality Engineer for a prominent client of ours. This position is located in St. Paul, MN. Details for the position are as follows:

Payrate: $35 - $37/hr W2

Job Title: Development Quality Engineer
Location: St. Paul, MN
Duration: 6 months contract – possible extension based on budget and performance.

Shift: 8am to 5pm.

Skills:

Hiring Manager is seeking the following skills: 1. NCMRS 2. CAPA'S 3. Any process Validation Experience 4. Operations Quality Design 5. Development Quality 6. Verbal and written communication 7. Interpersonal, teamwork, individual contributor 8. Multitask, strong organizational experience 9. Advanced computer skills
1-4 yrs experience
Candidates that have worked in the Medical Device Field Experience is a plus.

Job Description:
Skills:
Verbal and written communication, interpersonal, teamwork, individual contributor, multi task, strong organizational, advanced computer skills

Education:
Bachelor level degree in an Engineering Discipline or other technical field experience

Duties:

Participate in or lead teams in supporting quality disciplines, decisions, and practices, lead on-time completions 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
Endure DHF content completion, integrity and regulatory & standards compliance, collaborative communication 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 tech 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
Support all company initiatives as identified by management and in support of quality management systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements
Additional duties may be identified by functional management based on the current project/business objectives.

If you are interested in hearing more about the position please respond to this posting with your resume attached or contact me at 813 489 6265.

Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate who is hired and still gainfully employed after 30 days.

Source : The Fountain Group