Quality Manager, Product Development

Overview

Trelleborg 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, 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.

• 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.
• 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.

Salary range: $,000/year

• 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.

NOTE:

This job description is not intended to be all-inclusive. Employees may perform other related duties as required to meet the ongoing needs of the organization.

• Mid-Senior level

• Full-time

• Quality Assurance
• Industries

Note:

The description contains references to other roles and postings and is not limited to the NPD Quality Manager position.