- 2-4 years as a Sr. Manager of Quality (special focus on design and customer quality), Design Assurance and/or R&D function or equivalent experience
- Previous experience at the Director level preferred but not required BS in Engineering or other relevant field of study
- Minimum of 10 years experience in a manufacturing and product development environment (Medical Device experience highly desired)
- Prefer 15 years full time work experience Master's Degree or equivalent preferred.
- Six Sigma experience, CQE/CQM/PE certification preferred.
- Formal training in Quality Systems.
- Must be able to communicate with large groups of people.
- Must be able to review printed materials.
- Must be able to generate and explain detailed proposals, guidelines, and procedures for the Quality function to departmental and/or non-departmental personnel.
- Must be able to analyze and resolve non-routine product issues using independent judgment.
- Must be able to routinely make decisions which affect immediate operations and may have a company-wide effect.
- Must be able to observe and correct minute inconsistencies (e.g. in the printed word, a production process, product appearance, etc.).
- Must be willing to travel (25%) and spend time in the operating room, cadaver and animal labs and visit customers or teams in other geographies as needed
- Excellent analytical skills.
- Excellent interpersonal skills.
- Demonstrated effective managerial skills.
- Excellent organizational skills.The Director of Quality Assurance will:
- Provide a strategic direction and tactical focus to the Quality Assurance organization and influence the direction of divisional QA activities (specifically Design and Customer Quality)
- Own cradle to grave (Pre and Post Market) from New Product Development to obsolescence, quality of all products in the business
- Launch new products with high quality and ensure quick resolution to quality issues on launched products as well as work closely with several functions including salesforce, marketing, R&D, product engineering, field service, operations, Project management etc.
- Ensure that manufacturing, product development, and related functions are conducted in compliance with international standards and government regulations in support of company mission.
- Establish standard process to ensure appropriate resolution and management of the responsible task owner.
- Chair meetings required to drive closure of quality issues.
- Manage and provide updates for quality metrics.
- Implement appropriate enhancements.
- Review regulatory compliance requirements for changes affecting device manufacturing in global markets.
- Support quality system changes to support evolving regulations and international standards.
- Represent quality processes during internal and external audits.
- Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.
- Recruit, select, and on-board top talent.
- Develop talent within team to increase performance.
- Actively address performance issues on team.
- Maintain a high level of team engagement.Compensation:
$240,000 - $265,000 annually
If you are having difficulty in applying or if you have any questions, please contact Julia Ahadi at (+1) or
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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Director of Quality Assurance - San Jose, United States - Proclinical Staffing
Description
Director of Quality Assurance - Permanent - Onsite
Proclinical Staffing is seeking a Director of Quality Assurance to join an innovative medical equipment organization. This is a permanent role located in San Jose, CA.
Skills & Requirements: