Quality Engineer
12500 Whitewater Drive Minnetonka, MN 55343 US
Job Description
This position leads quality engineering activities for the entire product life cycle of commercial and development combination products. Â This position also participates in quality engineering activities for commercial scale up prior to product launch and supports contract manufacturing. Â The position covers a wide variety of quality engineering tasks and therefore requires a broad knowledge of quality engineering principles. Â
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsibilities include, but are not limited to:
•   Evaluates mechanical product design and identifies potential design quality issues and drives technical decisionsÂ
•   Leads and supports DHF and DMR content completion, integrity, and regulatory & standards compliance; collaboratively communicating and resolving gaps
•   Leads CAPA/NCR/SCAR investigations and reports
•   Supports and ensures the establishment of objective, measurable, discrete, and verifiable customer and product requirements
•   Supports engineering print specification definitions, development, and changes
•   Leads preparation and maintenance of risk management files from product conception through post market surveillanceÂ
•   Develops and maintains product release testing plans, associated test methods and procedures
•   Supports design test and inspection method development and validation
•   Supports design verification/validation and reliability study execution and deliverables; ensures compliance with quality system regulations
•   Identifies and leads continuous improvement projectsÂ
•   Leads complaint investigations
•   Leads quality system improvements as required
•   Support contract manufacturing activities including Process Development, Process Validation (IQ/OQ/PQ), Change Control and Nonconformance Resolution
•   Responsible for maintaining a strong collaborative partnership with cross-functional team members, CMOs and customers that facilitates organizational success by protecting patient/user safety and meeting business needs.
•   Performs other related duties as assigned
EDUCATIONAL REQUIREMENTS (degree, license, certification):
•   Bachelor level degree in Engineering (Mechanical, Material Science or Biomedical) or related Physical/Biological Science
YEARS OF EXPERIENCE:
•   5+ years relevant experience within the medical device industry or related function
OTHER SKILLS AND ABILITIES:
•   Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
•   Validation Experience highly preferred
•   Good statistical data analysis skills
•   Lead auditor certification preferredÂ
•   Six Sigma Belt preferred
•   Background in manufacturing processes for drug-device combination products related to development and commercial programs a plus
•   Ability to manage multiple projects
•   Excellent verbal and written skills
•   Able to work independently, as well as in a team environment
•   Customer focused and service oriented
•   Ability to educate stakeholders, customers and management
•   Ability to interface with internal customers, 3rd-party partners, Health care providers (HCPs) and regulatory agencies
•   Experienced working with cross-functional teams
•   Excellent communication skills (verbal and written)
•   Experienced with participation in audits
•   ASQ certification a plus
•   Travel up to 10-20%
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