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.
Tasks and Responsibilities
- 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.
Education and Experience
Required :
4-year degree in Engineering or Science-related field6 years of increasing experience providing technical support and leadership in medical device manufacturing environment2 years Leadership / Supervisory-level experience, with decision-making authority / responsibilityQuality certifications (ASQ CQE, CQA, CQM, etc.)Class I, II, III Medical Device Manufacturing experienceKnowledge and experience with ISO / FDA : ISO 9000 / 9001; ISO 13485, and 21CFR Part 11 / 820 (and 4 / 210 / 211 as applicable)Desired
Experience in coaching and utilizing performance management tools and disciplinesExperience in a CMO producing Medical DevicesExperience with ERP, Document Control, MES, and other types of softwareExperience auditing (internal and external) for all elements of ISO 9001 and / or ISO 13485Experience with the successful completion of multiple projects for new product development or improvement initiativesExtensive experience with statistical analysis, Minitab software (or equivalent), GD&T and CAPA investigation and resolutionCompetencies
Ability to read, write, speak and understand the English languageAbility to communicate clearly by conveying and receiving ideas, information and direction effectivelyAbility to demonstrate adequate job knowledge to deliver a world class performanceAbility to challenge oneself to consistently meet all goals and deadlinesWillingness to strive for excellence by producing work that is free of errors and mistakesDemonstrated active leadership skillsStrong statistical background and understandingAbility to lead cross functional groups for continuous improvement projectsAbility to apply Six Sigma Methodologies to manufacturing processes and experience teaching others these techniquesStrong verbal, written, organizational and interpersonal skills. Ability to communicate clearly and effectively to customers either in person or via video or telephone conferenceAbility to work flexible schedule as required by workload / projectAs a valued team member with Trelleborg, you will enjoy :
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.
Salary range : $109,000-125,000 / year
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.
EEO Statement