Quality Director, medical device manufacturing

Imagine leveraging your strong Quality experience for one of the leading contract manufacturers in the world. Seize this rare opportunity to be part of an exciting Healthcare and Medical Business Unit with the support and stability of an organization that has been in business for over 100 years.

Trelleborg Medical Solutions is seeking a Quality Director to join their team. The position is responsible for the Leadership and management of personnel and resources to ensure adherence and compliance to Trelleborg Medical Solutions Quality Management System (QMS) processes and policies.

Qualifications:

Required:

• 4-year degree in manufacturing or industrial engineering, quality assurance, regulatory affairs, science, or related field
• 10 years’ experience in quality assurance and/or regulatory affairs
• 5+ years Leadership/Supervisory-level experience, with decision-making authority/responsibility
• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, FDA 21CFR 820/11 (4/210/211) and other Regulatory as applicable
• Class I, II, and/or III (or equivalent) medical device manufacturing experience
• Auditor certificate or equivalent experience with both internal and external regulatory agencies

Desired:

• Master’s degree in science, engineering, or equivalent
• ASQ Certification for CQA, CQM, Lean Six Sigma Black Belt Certification
• 5 years in Medical Device or Medical Device Supplier environment

Responsibilities:

• Drive, conduct periodic reviews, and support QMS initiatives as well as implement and report on continuous improvement activities.
• Ensure the promotion and awareness of regulatory and customer requirements throughout the organization.
• Establish and monitor Quality Department goals and objectives.
• Ensure and manage the processes and functions needed for employees to execute, implement, and maintain Quality Systems and its standards, specific to:
• Corrective Action/Preventative Action System
• Quality Manual
• ISO Certifications
• Equipment/Software/Environmental Control System
• Non-conformance System
• Document and Record Control System
• Supplier Quality and Materials Control System
• Management Control System

Customer Feedback/Control System

ITAR (Empowered Official Responsibility)

• Quality Systems supporting Production and Process Controls
• Provide resources for new product reviews and customer correspondence pertaining to projects or complaints.
• Provide resources for review, control and maintenance for all Quality System required documentation.
• Manage, develop, mentor, coach, and review Quality department employees.
• Manage annual internal audits on all relevant Quality Systems and serve as Quality representative for Customer and Regulatory audits.
• Serve as the Quality Management representative for the organization.
• Ensure establishment and maintenance of site regulatory registrations.
• Lead and/or support QS integrations for existing and future organizational acquisitions.
• Support for integration of new manufacturing capabilities, product transfers, development programs, and customers.
• Promote and support a Quality Culture throughout the organization.
• Other duties as assigned

Competencies:

• Ability to read, write, speak and understand the English language
• Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
• Ability to demonstrate adequate job knowledge to deliver a world class performance
• Ability to challenge oneself to consistently meet all goals and deadlines
• Willingness to strive for excellence by producing work that is free of errors and mistakes
• Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
• Commitment to making improvements company wide
• Demonstrated competence using Microsoft Office
• Demonstrates senior leadership abilities with capability to accept responsibility and delegate authority
• Professional demeanor working with others
• Good math skills
• Good technical writing skills
• Working computer knowledge of Word, Excel
• Comprehensive working knowledge of applicable corporate policies, Work Instructions, and other procedures
• Ability to give directions, make decisions, give constructive criticism
• Competent knowledge of quality control evaluation devices including comparators, microscopes, pull tester, scales, and gauges
• Ability to interpret engineering drawings, specifications and other customer documents to support required inspections
• Ability to maintain a professional and respectful relationship with coworkers and company
  • Desire to delight both internal and external customers by offering encouragement, fostering teamwork and addressing conflict appropriately
• Statistical analysis, technical writing, non-contact measurement device

Geography to cover and travel requirements.

Up to 25% travel, as required