Quality Manager

Quality Manager (Direct Hire)

RosevilleCA

Job Requisition:  6597

Description for Quality Manager:
In a pivotal role on the quality engineering team, you will be the driving force behind the quality of some of the company’s most innovative products. You will provide leadership and drive results in all aspects of product development and manufacturing in order to ensure the highest level of quality in new and existing products, and their compliance to applicable regulations and standards. Your efforts will directly impact the safety of patients around the world who use the company’s products. You will apply your passion for detailed analysis for identifying problems and determining the appropriate course of action. You will be looked to for communicating quality objectives and building a culture of quality throughout the company. 

Responsibilities for Quality Manager: 
  • As a leader, manage the quality engineering functions in support of production to ensure conformance to the Penumbra Quality Management System, FDA QSR, ISO standards, and other regulatory requirements within a multidisciplinary team
  • Direct management of Quality Engineers that support quality inspection and manufacturing of Penumbra products
  • Mentor and develop cross-functional team members with the mentality that their success is your success
  • Provide subject matter expertise with external/internal audits, design of experiments, process validations, statistics, test method validations, measurement system analysis, sterilization validations, new product development, and risk
  • Take the lead on continuous improvement initiatives
  • With your top-notch critical thinking, find ways to make Penumbra's quality system better
  • Ensure product quality associated with our most robust array of product lines
  • With a high level of customer service, provide engineering support to designated production lines
  • Support the vendor management process to maintain strong relationships with suppliers
  • Continually improve technical processes and ensure reliability; implement inspections that meet Penumbra's quality standards
  • Manage the Key Performance Indicators (KPIs) for assigned product families and functional production areas
  • Assess, develop, evaluate, implement, and maintain process control systems
Requirements for Quality Manager:
  • Bachelor’s degree required (mechanical, biomedical, or materials engineering preferred)
  • 5+ years of previous medical device industry experience required
  • 1+ years of leadership experience required; people management experience highly preferred
  • Class III (preferred) or Class II medical device experience required
  • Proven track record of working with applicable regulations and standards, e.g. QSR, ISO 13485 required
  • Previous manufacturing engineering or process development experience preferred
  • Strong experience in Root-Cause Analysis (RCA)
  • Versatility, flexibility, and willingness to work within a dynamic environment
  • The ability to present issues, plans, and objectives in a clear, compelling way, both verbally and through documentation preferred
  • Proven work history of growing within an organization, learning its systems, and showing initiative preferred
  • Deep understanding of sterilization and biocompatibility preferred
  • Working knowledge of data collection, data analysis/evaluation, and scientific methodology
Desired Skills for Senior Quality Engineer:
  • ASQ Quality Certifications are strong desired
  • Lean/Six Sigma Certifications
  • Previous experience with the transfer and/or start-up of new production lines
 

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