Trelleborg Medical Solutions
Quality Manager, New Product Development
Trelleborg Medical Solutions, Minneapolis, Minnesota, United States, 55447
Overview
Trelleborg Medical Solutions is seeking a NPD Quality Manager to join their team. The NPD Quality Manager provides leadership for the NPD Quality Team within the Innovation Center or remotely located at an H & M Manufacturing site, with varying degrees of expertise and experience. 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, optimizing both human and capital resources through continuous improvement activities.
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 principles 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.
Qualifications
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).
Required Skills
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 Salary range: $109,000-125,000/year
Benefits and Highlights
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: Climate-controlled environment.
Growth and advancement: Global company with opportunities to advance.
Impact: Opportunity to contribute to life-saving devices.
Equal Opportunity 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. Trelleborg is an equal opportunity employer.
There is no request for additional information or contact details in this description.
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Trelleborg Medical Solutions is seeking a NPD Quality Manager to join their team. The NPD Quality Manager provides leadership for the NPD Quality Team within the Innovation Center or remotely located at an H & M Manufacturing site, with varying degrees of expertise and experience. 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, optimizing both human and capital resources through continuous improvement activities.
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 principles 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.
Qualifications
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).
Required Skills
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 Salary range: $109,000-125,000/year
Benefits and Highlights
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: Climate-controlled environment.
Growth and advancement: Global company with opportunities to advance.
Impact: Opportunity to contribute to life-saving devices.
Equal Opportunity 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. Trelleborg is an equal opportunity employer.
There is no request for additional information or contact details in this description.
#J-18808-Ljbffr