Careers in MedTech

Job Title

Mgr Quality Operations

Company

Truvic

Description

SUMMARY:

Responsible for the quality oversight of the manufacturing operations ensuring that all company products meet quality standards before they are distributed into commerce.  This role is responsible for analyzing, implementing, and executing processes to ensure product quality and compliance to the Quality System and applicable regulatory requirements.  Responsibilities include developing quality metrics and helping the company apply them intelligently and consistently. Broadly responsible for or is a stakeholder in Product Quality; Data Quality; Process Quality; Solutions to challenging quality problems.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.  Other duties may be assigned on an individual basis:

  • Responsible for the oversight of the finished product acceptance activities
  • Help specify and develop product acceptance criteria/test procedures for purchased subassemblies, components, and final assemblies
  • Manage all departmental employee related activities, including the day-to-day resourcing, hiring, mentoring, and on-going development to the staff
  • Train and mentor engineers and other project team members on best practices in quality engineering and regulatory compliance to external standards
  • Manage the non-conforming materials program, including leading/supporting investigations
  • Review and approve validation protocols and reports
  • Develop and monitor contract manufacturer quality metrics and goals and provide data-driven recommendations to senior management. Lead quality forums with the CMs
  • Responsible for the oversight and evaluation of the sterilization process and related suppliers
  • Collaborates with Operations to close out audit findings or corrective actions
  • Analysis of product failures and reliability opportunities; metrics; deep failure analysis; assistance in project management of projects that address said failures; metrics of improvement
  • Lead or participate on project teams to improve/monitor manufacturing quality issues/performance, or component design improvement activities
  • Develop, implement, and monitor various quality metrics. Identify opportunities for continuous improvement and customer satisfaction. Compile and represent data for quality process reviews
  • Gather and analyze data for root cause analysis. Coordinate and drive efforts to assure non-conformance and/or corrective action activities are opened and completed appropriately
  • Work with Engineering and Manufacturing to develop and implement process corrective actions
  • Project management help for a series of product, compliance, and quality projects
  • Ensure compliance to regulatory requirements. Uphold quality system. Support internal and external audits
  • Participate in internal and external audits for quality systems, processes, and products to ensure compliance with regulations and internal specifications
  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA/MDD regulations.

EDUCATION/EXPERIENCE:

  • BS in Engineering or related discipline and 8+ years of related experience; or MS in Engineering with 6+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry
  • 2+ years of supervisory experience strongly preferred
  • Through applied knowledge of ISO 13485, ISO 14971, IEC 60601 standards and 21 CFR 820 and MDD regulations
  • Knowledge of quality control process and statistical techniques
  • Strong analytical and problem-solving skills; strong attention to detail
  • Working knowledge of lean manufacturing, Six Sigma, Project Management principles a plus
  • CQE or CQM certification a plus
  • Lead auditor certification a plus
Published
June 29, 2022
Location
1359 Dell Ave, Campbell, CA
Category
Medtech  
Job Type
Only registered members can apply for jobs.
Related Jobs