Trelleborg Medical Solutions · 2 days ago
Quality Manager, New Product Development
Plymouth, MN
Full-time
Hybrid
Mid, Senior Level
$109K/yr - $125K/yr
6+ years expTrelleborg Medical Solutions is seeking a NPD Quality Manager to join their team. The NPD Quality Manager provides leadership for NPD Quality Team within the Innovation Center or remotely located at an H & M Manufacturing site, overseeing quality initiatives for new product development.
Medical Device
Hiring Manager
Gabrielle Gutzwiller
Responsibilities
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
Qualification
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 21CFR 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
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 effectively to customers either in person or via video or telephone conference
Ability to work flexible schedule as required by workload/project
Benefits
Competitive compensation: Plus, bonus opportunities!
Generous benefits package: Includes health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more!
Clean work environment: Enjoy working in a very clean and climate-controlled environment every day!
Greater opportunity for impact: You will impact the production of life-saving devices.
Growth and advancement: Join a global company that loves to promote from within and allows for advancement.
Company
Trelleborg Medical Solutions
Trelleborg Medical Solutions partners with the world’s leading medical device and biopharmaceutical companies, collaborating from concept to commercialization to bring to market impactful solutions that improve patient quality of life.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase