Trelleborg Group
Quality Manager - Med Device New Product Development
Trelleborg Group, Delano, Minnesota, United States, 55328
Quality Manager - Med Device New Product Development
Join to apply for the Quality Manager - Med Device New Product Development role at Trelleborg Group
Overview 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 customer demand. Optimizes both human and capital resources through continuous improvement activities.
Responsibilities
Provides leadership for the NPD Quality Team within the Innovation Center or at an H&M Manufacturing site, with varying degrees of expertise and experience.
Manages and oversees all aspects of the H&M NPD Quality Team (multiple sites) involved in quality related product/program development projects from conceptualization and validation through release to manufacturing.
Adheres to H&M Trelleborg Quality Management System and its requirements.
Drives and supports QMS initiatives and continuous improvement activities.
Ensures direct reports perform their duties; provides ongoing coaching.
Assigns projects and responsibilities to staff; aligns skill-sets with duties.
Establishes and develops site-specific processes as required.
Reviews and approves processes, Quality Plans, protocols, and reports as necessary.
Allocates resources to meet delivery expectations of customers.
Provides recommendations for goals and objectives for the Quality Department.
Works with internal resources to establish processes and resolve issues.
Drives best practices through quality engineering principles across functions.
Ensures controls are applied to new and legacy products.
Supports internal and external audits.
Provides data-driven recommendations for measurable improvements.
Qualifications
4-year degree in Engineering or Science-related field.
6 years of increasing experience providing technical support and leadership in a medical device manufacturing environment.
2 years of leadership/supervisory 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).
Desirable
Experience coaching and using performance management tools.
Experience in a CMO producing Medical Devices.
Experience with ERP, Document Control, MES, and other software.
Experience auditing (internal and external) for ISO 9001 and/or ISO 13485.
Experience delivering multiple NPD projects or improvement initiatives.
Extensive experience with statistical analysis, Minitab (or equivalent), GD&T and CAPA investigations and resolutions.
Competencies
English proficiency; strong communication skills.
Clear, effective communication and collaboration across functions.
Strong leadership and project delivery capabilities.
Ability to manage multiple priorities and deadlines; results-oriented.
Strong numerical and analytical skills; Six Sigma methodologies familiarity.
Ability to lead cross-functional teams for continuous improvement.
Ability to apply Six Sigma to manufacturing processes; mentoring others in these techniques.
Strong written and verbal communication with customers via in-person, video, or phone.
Flexible schedule as workload dictates.
Benefits and Compensation Salary range: $109,000 – $125,000 per year. Competitive compensation with bonus opportunities. Generous benefits package including health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more. Growth and advancement opportunities within a global company.
Note This job description is not all-inclusive. Employees may perform other related duties as required to meet the ongoing needs of the organization.
EEO Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other status protected by state or federal law.
Apply here #J-18808-Ljbffr
Overview 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 customer demand. Optimizes both human and capital resources through continuous improvement activities.
Responsibilities
Provides leadership for the NPD Quality Team within the Innovation Center or at an H&M Manufacturing site, with varying degrees of expertise and experience.
Manages and oversees all aspects of the H&M NPD Quality Team (multiple sites) involved in quality related product/program development projects from conceptualization and validation through release to manufacturing.
Adheres to H&M Trelleborg Quality Management System and its requirements.
Drives and supports QMS initiatives and continuous improvement activities.
Ensures direct reports perform their duties; provides ongoing coaching.
Assigns projects and responsibilities to staff; aligns skill-sets with duties.
Establishes and develops site-specific processes as required.
Reviews and approves processes, Quality Plans, protocols, and reports as necessary.
Allocates resources to meet delivery expectations of customers.
Provides recommendations for goals and objectives for the Quality Department.
Works with internal resources to establish processes and resolve issues.
Drives best practices through quality engineering principles across functions.
Ensures controls are applied to new and legacy products.
Supports internal and external audits.
Provides data-driven recommendations for measurable improvements.
Qualifications
4-year degree in Engineering or Science-related field.
6 years of increasing experience providing technical support and leadership in a medical device manufacturing environment.
2 years of leadership/supervisory 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).
Desirable
Experience coaching and using performance management tools.
Experience in a CMO producing Medical Devices.
Experience with ERP, Document Control, MES, and other software.
Experience auditing (internal and external) for ISO 9001 and/or ISO 13485.
Experience delivering multiple NPD projects or improvement initiatives.
Extensive experience with statistical analysis, Minitab (or equivalent), GD&T and CAPA investigations and resolutions.
Competencies
English proficiency; strong communication skills.
Clear, effective communication and collaboration across functions.
Strong leadership and project delivery capabilities.
Ability to manage multiple priorities and deadlines; results-oriented.
Strong numerical and analytical skills; Six Sigma methodologies familiarity.
Ability to lead cross-functional teams for continuous improvement.
Ability to apply Six Sigma to manufacturing processes; mentoring others in these techniques.
Strong written and verbal communication with customers via in-person, video, or phone.
Flexible schedule as workload dictates.
Benefits and Compensation Salary range: $109,000 – $125,000 per year. Competitive compensation with bonus opportunities. Generous benefits package including health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more. Growth and advancement opportunities within a global company.
Note This job description is not all-inclusive. Employees may perform other related duties as required to meet the ongoing needs of the organization.
EEO Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other status protected by state or federal law.
Apply here #J-18808-Ljbffr