Quality Manager

Lubrizol-posted 4 months ago
Full-time • Mid Level
Victor, MT
Chemical Manufacturing
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Join Our Thriving Team at Lubrizol as Quality Manager. Unleash Your Potential. At Lubrizol we're transforming the Medical Device industry and looking for exceptional talent to join us on this journey. If you are ready to join an international company with talent around the world, and want to make a real impact, we want you on our team.

  • Management representative for the facility regarding all Quality System issues.
  • Responsible for implementing and maintaining the Quality System for FDA and ISO requirements.
  • Manages all QA interactions with customers and other outside regulatory agencies.
  • Verifies investigations and customer complaints regarding quality and the corrective actions involved.
  • Establishes Quality Control testing, sampling and control strategies such as SPC.
  • Analyzes product and process quality data to identify and make recommendations for meeting organizational Quality objectives.
  • Acts as technical advisor on Quality Control matters.
  • Accountable for material release activities and final disposition, including process ownership of the MRB.
  • Establishes Measurement Systems Analysis processes.
  • Establishes goals and metrics related to people, processes and products for the Quality Control Department.
  • Provides input to the development of departmental and corporate performance objectives.
  • Identifies hires and develops Quality Control personnel to meet company and departmental objectives.
  • Directs the activities of the Quality inspection team and product support Quality Engineers.
  • Plans, promotes, and organizes training activities related to product quality.
  • Direct Process Owner for Process Controls.
  • Demonstrate flexibility and cooperative behavior with colleagues and supervisors at all times.
  • Observe and promote Company standards and policies on safety, quality and productivity.
  • Other duties as assigned.
  • Bachelor's degree preferably in the engineering or science fields.
  • 5+ years of experience in Medical Device industry.
  • Knowledge of ISO 13485:2003 at mastery level.
  • Experience with Measurement Systems Analysis, Statistical Process Control, Blueprint analysis and Process Validation.
  • Quality engineering/control experience.
  • Direct management/supervisory experience.
  • Certified Quality Engineer (ASQ) (preferred).
  • Certified Quality Manager (ASQ) (preferred).
  • FDA 21 CFR Part 820 at proficient level (preferred).
  • Six Sigma Green or Black Belt (preferred).
  • Lean Manufacturing (preferred).
  • Finished medical device company experience (preferred).
  • Competitive salary with performance-based bonus plans.
  • 401K Match plus Age Weighted Defined Contribution.
  • Competitive medical, dental & vision offerings.
  • Health Savings Account.
  • Paid Holidays, Vacation, Parental Leave.
  • Flexible work environment.
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