QUALITY ASSURANCE LOGISTICS MANAGER

Description

Who We Are

At KLS Martin, we offer a unique opportunity to contribute to the success of a dynamic and thriving company whose products are used daily across the world to help surgical patients. 

The KLS Martin Group is a worldwide leader in creating surgical solutions for the craniomaxillofacial and cardiothoracic fields. Surgical innovation is our passion, and we are constantly working with surgeons to improve surgical care for their patients. Our product portfolio includes titanium and resorbable implants for reconstruction, innovative distraction devices to stimulate bone lengthening, over 4,000 surgical instruments, and other surgical products designed specifically for CMF and cardiothoracic surgeons. 

KLS Martin is an innovative leader in the treatment of CMF deformities and trauma cases. We use Individual Patient Solutions (IPS) by using our proprietary IPS products where CT scans are used to custom design implants that are created specifically for that individual patient.  This technology allows our surgeons to provide the best-in-class treatment for their patients.

KLS Martin Guiding Principles

• Established, Privately Held Business Group – Responsive to customers, not shareholders. KLS Martin has manufactured medical products since 1896, and we have sold our products in the United States under the KLS name since 1993. We have always been, and always will be, privately owned.
• Patient Focus – We design products with the patient in mind – CMF, Thoracic & Hand
• Product to Table – Integrated planning, design, manufacturing and distribution process
• Educational Partner – Our primary focus for support is on education
• Inventory Alliance – Inventory management is critical to patient treatment/outcome
• Surgical Innovation is Our Passion – More than just a tagline

What We Offer

• We provide full-time employees with a competitive benefits package, including paid parental leave
• In-house training and professional development opportunities
• A culture of creativity and innovation by drawing on diverse perspectives and ideas to drive surgical innovation

Job Summary

Quality Assurance Logistics Manager leads the functions of Operations product quality assurance and inspection, to include Quality Assurance, Quality Assurance Returns/ Decontamination, and Servicing. Responsible for managing and ensuring the Quality Assurance teams and daily work processes comply as described by controlled procedures and processes. Ensure Quality and Safety compliance. Assist in Managing the IPS Quality Assurance Department as needed.

Essential Functions, Duties, and Responsibilities

• Responsible for managing and ensuring the Quality Assurance teams and daily work processes comply as described by controlled procedures and processes.  Ensure compliance to quality, safety, and drive continuous improvement initiatives.
• Lead and prioritize the activities of the Quality Assurance teams, ensuring that all products consistently meet or exceed quality standards.
• Perform essential Quality Assurance functions, including but not limited to Non-Conformance Material Reports (NCMR), product complaints, inspections, and decontamination processes.
• Ensure the continuous flow of products through quality inspection processes, maintaining efficiency and compliance.
• Ensure that incoming shipments meet specifications and requirements; have the authority to halt product releases if necessary.
• Ability to assess risks associated with logistics processes and implement effective controls to ensure the safe distribution of medical devices.
• Participate in and support both internal and external audits of the facility to ensure compliance with relevant standards.
• Plan and manage operational budgets for the Quality Assurance function, ensuring resource allocation is aligned with business goals.
• Manage the handling of product discrepancies and nonconforming materials, ensuring procedures are communicated and followed.
• Maintain and manage area-controlled documentation, ensuring proper retrieval and interpretation in compliance with business requirements.
• Lead and drive continuous process improvement initiatives to enhance product quality and operational efficiency.
• Manage staffing and team structure within the Quality Assurance department, addressing any necessary changes to ensure optimal performance.
• Perform other related duties as required to support the overall objectives of the business.

Qualifications

Educational and Experience Requirements

• Bachelor’s degree required.
• A minimum of 8 years’ experience in regulated industry specific to job role.
• Comprehension of 21CFR820, 13485 and application of the standards.
• CQA (Certified Quality Auditor) or CQE (Certified Quality Engineer) certification required
• Proficient user of Microsoft Office applications
• Use of SAP preferred but not required

Knowledge, Skills, and Abilities

• Adhere and support KLS Martin’s quality and safety policies and procedures.
• Ability to retrieve and interpret documentation.
• Strong organizational and time-management skills.
• Strong communication and leadership skills.
• Able to work in a team setting and independently under minimum supervision.
• Strong interpersonal skills with the ability to effectively communicate at all levels internally as well as externally.
• Problem solving & Decision Making / Adaptability & Flexibility
• High level of customer service displaying positive attitude.

Skill Requirements

• Typing/computer keyboard
• Utilize computer software (specified above)
• Retrieve and compile information
• Maintain records/logs
• Verify data and information
• Organize and prioritize information/tasks
• Operate office equipment
• Advanced mathematical concepts (fractions, decimals, ratios, percentages, graphs)
• Verbal communication
• Written communication
• Public speaking/group presentations
• Research, analyze and interpret information
• Investigate, evaluate, recommend action
• Leadership and supervisory, managing people
• Basic mathematical concepts (e.g. add, subtract)
• Abstract mathematical concepts (interpolation, inference, frequency, reliability, formulas, equations, statistics)

Physical Requirements

• Sitting for extended periods
• Extended periods viewing computer screen
• Walking
• Reading
• Speaking
• Hear/Listen
• Maintain regular, punctual attendance
• Lifting/carrying up to 20 pounds various items
• Lifting/carrying more than 20 pounds various items
• Repetitive Motions
• Pushing/Pulling
• Bending/Stooping
• Reaching/Grasping
• Writing

Hazards

• Warehouse environment

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

KLS Martin is a drug-free employer