Senior Development Quality Engineer # JN -022021-60288

Little Canada, Minnesota
Industry: Database Administrator / Engineers
Job Number: JN -022021-60288


Title:                   Senior Development Quality Engineer

Location:           Little Canada, MN

Duration:           8 months contract

Primary Duties and Responsibilities:

  • Lead on-time completion of Design Control deliverables 
  • Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
  • Accountable for Design Verification and Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities
  • Lead Risk Management activities, including analyzing field data to support new product development, and supporting Failure Mode Effects Analysis 
  • Support design test and inspection method development, and lead method validation activities
  • Ensure Device History File (DHF) content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating and resolving gaps
  • Support manufacturing process development and qualification for new product commercialization and product changes
  • Support internal and external audit responses and on-time product re-certifications
  • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
  • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications 
  • Support the development and review of biocompatibility and sterilization validations
  • Supports R&D product builds for bench testing, animal lab, and first in human activities.
  • Complete Document Change Request Reviews in a timely and objective manner
  • Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required.
  • Develop and lead other team members.

Other Duties:

  • Additional duties may be identified by functional management based on the current project/business objectives.
  • 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

Required Qualifications:

  • Bachelor’s degree within an Engineering field or related science-based discipline
  • 5-8+ years of related work experience
  • Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
  • Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
  • 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.

Preferred Qualifications:

  • Advanced degree in a technical field
  • Medical device experience, specifically with valves and /or implantable devices
  • Experience working in a broader enterprise/cross-division business unit model
  • Prior experience working with any or all of the following:
  • ISO 13485 Medical Devices – Quality Management System
  • 21 CFR Part 820 FDA Quality System Regulations
  • ISO 14971 Medical Devices – Application of Risk Management
  • EUMDR
  • MDSAP
  • Good Manufacturing Practices And Good Documentation Practices

 

 


Apply Online Apply Later