Imagine leveraging your quality & leadership skills while working for one of the leading contract manufacturers in the world. Seize this rare opportunity to be part of an exciting, Healthcare and Medical Business Unit with the support and stability of an organization that has been in business for over 100 years.
Trelleborg Healthcare and Medical is seeking a Quality Engineering Manager to join their team The Quality Engineering Manager is responsible for leading a team of Quality Engineers, as well as providing leadership, functional management and oversight of other designated areas.
As a valued Trelleborg team member, you will enjoy:
A fulfilling career with greater opportunity for impactA fun and rewarding company cultureCompetitive salaryGenerous benefits package: Health, Dental, Vision, STD, LTD, Life, 401kPaid time offPaid holidaysBonus
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 resolutionResponsibilities:
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 topicsEstablishes and develops site-specific processes as required/requestedReviews and approves processes, Quality Plans, protocols/reports, as necessary.Ensures proper resource allocation to support needs to ensure delivery expectations of customersProvides recommendations for goals and objectives for the Quality DepartmentWorks closely with internal resources to establish processes and resolve issuesDrives best practices through the application of effective quality engineering principals and procedures across functions