Quality Manager

Summary

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.

Salary Range: $135,000- $155,000

Tasks & Responsibilities

• Knowledgeable and adheres to TMS Quality Management System and its requirements.
• Provides leadership, guidance, and technical expertise to the NPD Quality Team and NPD organization
• 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.
• Consults customers on quality-related topics
• 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 & Experience

Required: 

• 4-year degree in Engineering or Science-related field
• 8+ years of increasing experience providing technical support and leadership in medical device manufacturing environment, including CMO
• 4+ 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 13485, EU/MDR, GHTF Validation Guidance, and 21CFR Part 11/820 (and 4/210/211 as applicable)

Desired:

• Experience in coaching and utilizing performance management tools and disciplines
• Extensive experience with statistical analysis, Minitab software (or equivalent), GD&T and CAPA investigation and resolution

Competencies

• Ability to read, write, speak and understand the English language
• Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
• Ability to demonstrate adequate job knowledge to deliver a world class performance
• Ability to challenge oneself to consistently meet all goals and deadlines
• Willingness to strive for excellence by producing work that is free of errors and mistakes
• Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
• Commitment to making improvements company wide
• Demonstrated competence using Microsoft Office
• Demonstrated active leadership skills
• Demonstrated ability to lead projects and get results through others
• High level of professionalism and collaboration in team settings
• 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
• Professional and proactive; able to work well independently or as part of a team
• Ability to work flexible schedule as required by workload/project

Application

Apply Here

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