Director of Quality Assurance

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:

• 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) 512-643-4324 or j.ahadi@proclinical.com.

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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