Quality Assurance Specialist

2 weeks ago

Brooklyn Park, Minnesota, United States Velosity Companies Full time

Join Velosity Companies as a Quality Assurance Specialist to enhance our manufacturing operations. We are looking for a dedicated professional to contribute to our facility's quality assurance efforts.

The Quality Assurance Specialist will collaborate with operational and project teams, offering statistical and technical expertise through direct evaluation of products and processes. This role is crucial in ensuring that we consistently fulfill our clients' expectations.

Key Responsibilities:

  • Analyze in-process data to identify trends, troubleshoot quality concerns, and provide actionable recommendations to both internal and external stakeholders.
  • Develop and execute qualification and validation plans, documenting results in compliance with company and client standards to support new product initiatives.
  • Lead quality investigations for assigned product line failures, ensuring thorough resolution.
  • Manage quality system records, including CAPA, NC, and Complaint documentation for the designated product lines.
  • Assist project teams in formulating risk management and control strategies to guarantee that our products meet customer specifications.
  • Identify and implement Statistical Process Control (SPC) opportunities to enhance current in-process controls.
  • Propose improvements for systems and products within assigned areas.

What We Offer:

  • Comprehensive benefits package, including medical, dental, life insurance, and disability coverage.
  • 401k matching and a quarterly bonus program.
  • Generous paid time off and nine paid holidays each year.
  • Opportunities for professional growth and advancement.
  • A clean, friendly, and climate-controlled work environment.
  • A collaborative culture that prioritizes employee development based on our core values.

Qualifications:

  • Bachelor's degree in Engineering or equivalent experience.
  • Certified Quality Engineer (CQE) is preferred.
  • Minimum of 5 years of experience in a Medical Contract Manufacturer, Medical Device, or Component manufacturing setting.
  • Strong written and verbal communication skills, including data interpretation and reporting.
  • Proficient in problem-solving and critical thinking to evaluate options and implement effective solutions.
  • Familiarity with PPAP, IQ, OQ, PQ, FMEA, CONTROL PLANS, DOE, GRR, and risk management.
  • Experience in regulated Quality Systems (e.g., ISO, AS, GMP) is preferred.
  • Background in thermoplastic injection molding, Swiss component manufacturing, or CNC machining is advantageous.

Work Environment:

This role is situated in a manufacturing environment, which may involve exposure to various elements such as heat, noise, and dust. The position requires physical activities including sitting, standing, walking, kneeling, bending, reaching, and the ability to lift up to 30 lbs.

Additional Information:

Velosity Companies is committed to maintaining a drug-free workplace and conducts pre-employment substance abuse testing. We are an Equal Opportunity/Affirmative Action Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, veteran, marital, or disability status.

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