Quality Manager - Health & Medical

Summary of Role

Trelleborg Sealing Solutions Health & Medical Business Unit, located in Northborough MA, is looking for a Quality Manager to join our growing team! This position is responsible for the leadership and management of personnel and resources to ensure adherence and compliance to US H&M Trelleborg Quality Management System (QMS) processes and policies.

Tasks & Responsibilities

• Reports on the performance of the Quality System (QS) for Management Review meetings and any need for improvement; prepares agenda and establishes records for Management Review meetings.
• Plans, manages, and controls programs and procedures that maintain an acceptable level of product quality as established by various federal, state, customer, and company requirements, including quality of purchased material, in-process material, and finished goods. 
• Provides leadership and guidance in implementing action for quality programs and for controlling quality costs.
• Serves as Management Representative for the QS and represent the Company in all audits.
• Ensures that processes needed for the QMS are established, implemented and maintained.
• Ensures the promotion of awareness of regulatory and customer requirements throughout the organization.
• Ensures establishment and maintenance of site regulatory registrations.
• Supports, coordinates and oversees site customer-requested, external regulatory, and internal audits.
• Provides oversight and ensure compliance of QS support elements for the site QMS: Internal audits, Training, Document Control, Supplier Quality Management, Complaint Management, CAPA, NC Management, and Calibration Systems
• Reviews and approves of QS documents.
• Maintains higher level quality system documents including Quality System Manual (QSM), Work Instructions (WI), Standard Operating Procedures (SOP) related to Quality.
• Ensures that processes needed for the quality management system are established, implemented and maintained.
• Manages the internal audit program including planning, scheduling, review and approval of audits.
• Has responsibility for product quality issues (i.e., supplier evaluations and approvals, inspection, test and measurement, nonconforming product, etc.)
• Supports Material Review Board (MRB) activities for nonconforming product.
• Has responsibility for the Corrective and Preventive Action (CAPA) system, complaint handling system, training program, documentation control system, and quality records.
• Supports validation activities and approvals, as needed.
• Provides quality training for personnel as needed.
• Maintains compliance to customer Quality Agreements, as required.
• Other activities as assigned/needed

Education & Experience

• 4-year degree in manufacturing or industrial engineering, quality assurance, regulatory affairs, science or related field
• 5+ years of experience in Quality Assurance and/or Regulatory Affairs
• Auditor certificate or equivalent experience
• 3 years supervisory experience

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
• Demonstrate senior leadership abilities with the capacity to accept responsibility and delegate authority.
• Good managerial, analytical, organizational, and communication skills.
• Math and computer literate.
• Understanding of basic statistics.
• Competent knowledge of equipment and manufacturing operations.
• Thorough understanding of Validations (including equipment qualification (IQ/OQ), process validation, test method validation, computer systems and software validations, etc.); understanding of process capability.
• Thorough understanding of medical device quality system standards, specifications, laws, and regulations, i.e., FDA Quality System Regulations (21 CFR Part 820) and Current Good Manufacturing Practices (21 CFR Part 210 & 211), ISO 13485, and other industrial standards as applicable.
• Correctable normal reading distance vision.
• Knowledge of product drawings, specifications as well as measuring and testing devices.
• Comprehensive working knowledge of applicable corporate policies and quality system documentation.
• Ability to maintain a professional and respectful relationship with coworkers and company.

Application

Last Application Date: March 16, 2024

Apply Here

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