IPS Quality Assurance Manager (33247)

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

IPS Quality Assurance Manager leads the functions of Operations product quality assurance and inspection, to include: IPS Administration, Individual Patient Solutions (IPS) Quality Assurance, KLS Martin Manufacturing receiving, Shipping of IPS, and quality inspections of KLS Martin Manufacturing devices and raw materials. This role also contributes to the development, implementation, and administration of the quality management systems and monitor progress to continuously improve processes.

Essential Functions, Duties, And Responsibilities

Quality Oversight & Compliance

• Lead and manage product quality assurance activities across Operations, including Individual Patient Solutions (IPS) and KLS Martin Manufacturing.
• Ensure ongoing compliance with applicable regulatory standards such as FDA, ISO 13485, and cGMP, as well as internal quality system requirements.
• Uphold and enforce adherence to company quality policies, standard operating procedures, and quality standards.
  
  

IPS Administration & Quality Assurance

• Oversee all quality assurance processes related to IPS, ensuring that patient-specific products meet regulatory, design, and quality requirements.
• Supervise the review, inspection, and approval of IPS documentation to support product release and compliance.
  
  

Inspection & Receiving

• Manage incoming inspection activities for raw materials and finished goods received from KLS Martin Manufacturing.
• Develop, implement, and maintain clear inspection protocols and acceptance criteria.
• Ensure proper identification, segregation, documentation, and disposition of nonconforming materials.
  
  

Shipping Quality Assurance

• Oversee quality control processes for IPS product shipments, ensuring appropriate packaging, labeling, and documentation are in place.
• Coordinate final inspections and product releases in alignment with shipping schedules and compliance requirements.
  
  

Quality Management System (QMS) Administration

• Support the development, implementation, and ongoing improvement of the Quality Management System.
• Participate in internal and external audits and maintain documentation in support of CAPA, change control, and document control processes.
  
  

Team Leadership & Development

• Lead, coach, and develop QA inspectors and staff involved in quality inspection and operations.
• Foster a strong quality culture focused on accountability, continuous improvement, and regulatory compliance.
  
  

Process Improvement & Metrics

• Analyze quality metrics and trends to identify risks and improvement opportunities.
• Define, track, and report key performance indicators (KPIs) related to quality assurance performance.
• Lead or support root cause investigations and ensure effective implementation of corrective and preventive actions.
  
  

Cross-Functional Collaboration

• Work closely with Engineering, Manufacturing, Regulatory Affairs, and Supply Chain teams to ensure end-to-end product and process quality.
• Actively contribute to design reviews, process validations, and risk assessments to support quality goals.
  
  

Qualifications

Educational and Experience Requirements

• Bachelor’s Degree in Quality Assurance, Life Sciences, or related field.
• 6 years of experience in Quality Assurance Leadership.
• A minimum of 6 years’ experience in regulated industry specific to job role.
• Comprehension of 21CFR820, ISO 13485 and application of the standards.
• Proficient user of Microsoft Office applications
• Previous experience with ERP system, SAP preferred
  
  

Knowledge, Skills, And Abilities

• Ability to work effectively with all levels of internal and external stakeholders at all organizational levels, fostering positive and productive relationships.
• Demonstrated ability to effectively communicate both verbally and in writing.
• Ability to develop and maintain collaborative relationships with all levels within the organization.
• Ability to follow through on issues, make informed decisions that comply with policies and procedures, complete tasks and problem-solve.
• Ability to manage multiple priorities.
• Possess intermediate to advanced level knowledge of Microsoft Office software applications, ERP systems, and SQL.
  
  

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