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. This position also participates in quality engineering activities for commercial scale up prior to product launch and supports contract manufacturing. The position covers a wide variety of quality engineering tasks and therefore requires a broad knowledge of quality engineering principles.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsibilities include, but are not limited to:
• Evaluates mechanical product design and identifies potential design quality issues and drives technical decisions
• 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 surveillance
• 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 projects
• 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 preferred
• 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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