Quality Assurance Engineer in Manufacturing

2 months ago


Minneapolis, Minnesota, United States a Medical Devices company located in MN Full time

Manufacturing Quality Engineer (Contract)

KEY RESPONSIBILITIES

  • Designing, executing, and refining manufacturing methodologies to optimize yield, minimize expenses, and boost operational efficiency.
  • Acting as the Process Engineering representative in Research & Development and Project Team discussions, offering technical insights on technology transfers, analytical method formulation, validation, and process scaling.
  • Overseeing or conducting process validations (IQ/OQ, OQ, PQ).
  • Diagnosing and resolving production line challenges concerning yield, quality, and throughput.
  • Facilitating the transition of processes from development stages to large-scale manufacturing.
  • Assisting in the assessment of Non-Conformance Material Reports (NCMR), Corrective and Preventive Actions (CAPA), Supplier Corrective Action Requests (SCAR), Failure Investigations, and Deviation inquiries from Contract Manufacturers/Suppliers.
  • Generating and revising manufacturing guidelines, routing documents, bills of materials, and Standard Operating Procedures (SOPs).

REQUIRED QUALIFICATIONS

  • At least 4-5 years of experience in the medical device manufacturing sector.
  • Proficient in Design Transfer and Process Validations with external suppliers (Contract Manufacturing Organizations).
  • Ability to draft and implement related validations.
  • Strong analytical capabilities and problem-solving proficiency (Design of Experiments, Statistical Process Control, Six Sigma).
  • Familiarity with Class II/Class III medical device manufacturing and associated quality system regulations.
  • Proven track record of meeting deadlines, demonstrating effective project planning and management skills.
  • Exceptional verbal and written communication abilities; adept at engaging with both technical and non-technical stakeholders.
  • Capability to provide clear direction and support to external partners and suppliers.
  • Experience with electromechanical assemblies is advantageous.
  • Background in Design for Manufacturing is preferred.
  • Experience in fixture development is a plus.
  • Exposure to early-stage product development is desirable.

EDUCATIONAL BACKGROUND

  • Bachelor's degree in Biomedical Engineering, Manufacturing Engineering, Mechanical Engineering, or a related life sciences field.
  • Six Sigma Certification is preferred.


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