NPD Quality Manager - medical device

Trelleborg Medical Solutions is seeking a NPD Quality Manager to join their team. The NPD Quality Manager develops and achieves New Product Development (NPD) Quality initiatives to support Trelleborg Goals and Objectives. Oversees the Validation and verification requirements of new products/programs as well as ensuring that all related quality activities are carried out in accordance with industry standards and regulations. Manages overall NPD Quality resources and ensures that capacity and capability meet the customer demand.

Optimizes both human and capital resources through continuous improvement activities.

• Provides leadership for NPD Quality Team within the Innovation Center or remotely located at an H & M Manufacturing site, with varying degrees of expertise and experience
• Manages & oversees all aspects of the H&M NPD Quality Team (multiple sites) involved in quality related product/program development projects from conceptualization & validation phase through release to manufacturing
• Must be knowledgeable and adhere to H&M Trelleborg Quality Management System and its requirements
• Drives and supports QMS initiatives and continuous improvement activities.
• Ensures direct reports are successfully performing their duties as assigned. Provides coaching on an ongoing basis.
• Assigns projects and responsibilities to the direct reports. Ensures skill-sets of staff are in alignment with expected duties.
• Establishes and develops site-specific processes as required/requested
• Reviews and approves processes, Quality Plans, protocols/reports, as necessary.
• Ensures proper resource allocation to support needs to ensure delivery expectations of customers
• Provides recommendations for goals and objectives for the Quality Department
• Works closely with internal resources to establish processes and resolve issues
• Drives best practices through the application of effective quality engineering principals and procedures across functions
• Ensures proper controls are being systematically applied to both new and legacy products
• Supports internal and external audits
• Provides recommendations based on data for improvements that are measurable.

Required:

• 4-year degree in Engineering or Science-related field
• 6 years of increasing experience providing technical support and leadership in medical device manufacturing environment
• 2 years Leadership/Supervisory-level experience, with decision‑making authority/responsibility
• Quality certifications (ASQ CQE, CQA, CQM, etc.)
• Class I, II, III Medical Device Manufacturing experience
• Knowledge and experience with ISO/FDA: ISO 9000/9001; ISO 13485, and 21
  
  CFR Part 11/820 (and 4/210/211 as applicable)
• Experience in coaching and utilizing performance management tools and disciplines
• Experience in a CMO producing Medical Devices
• Experience with ERP, Document Control, MES, and other types of software
• Experience auditing (internal and external) for all elements of ISO 9001 and/or ISO 13485
• Experience with the successful completion of multiple projects for new product development or improvement initiatives
• Extensive experience with statistical analysis, Minitab software (or equivalent), GD&T and CAPA investigation and resolution
• 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
• Demonstrated active leadership skills
• Demonstrated ability to lead projects and get results through others
• Ability to manage tasks with competing priorities and deadlines
• Proven team‑building skills
• Strong statistical background and understanding
• Ability to lead cross‑functional groups for continuous improvement projects
• Ability to apply Six Sigma Methodologies to manufacturing processes and experience teaching others these techniques
• Strong verbal, written, organizational and interpersonal skills. Ability to communicate clearly and…