To support the mission of delivering the highest quality product to our customers, the Quality Manager is responsible for ensuring that incoming custom components conform to design specifications and that all finished goods meet consistent quality standards. In addition to contributing to the overall success of the Engineered Solutions group, the Quality Manager is responsible for numerous daily activities listed below.

Duties/Responsibilities:

• Manage a team of Quality Inspectors who are responsible for performing incoming inspection of custom components, Work in Process (WIP) inspections, as well as finished goods inspections
• Work with the Quality Inspector team to establish inspection methods for custom parts and identify and procure appropriate measurement tooling, which may include the development of go/no-go gauges
• Manage the team that oversees the calibration program for certain production tooling
• Develop, implement, and manage Olympus Controls Quality Management System (QMS), ensuring conformance to internal, customer, and ISO 9001 requirements including supervising and performing the internal audits
• Work closely with the Return Merchandise Authorization (RMA) coordinator to manage the processing, documentation, and reconciliation of non-conforming or RMAd materials
• Lead the investigation, execution and completion of corrective action requests from customers
• Work collaboratively with the Manufacturing Engineer, Production Manager, and Engineering team to establish new production lines and/or improve the efficiency of existing ones
• Provide technical support for the production team
• Work closely with the person(s) responsible for documenting standard operating procedures, work instructions, and job aids to ensure accuracy and adherence to company standards
• Perform final, gating quality inspections as part of Factory Acceptance Testing (FAT) and verify appropriate testing has been completed
• Attend and proactively engage in various company meetings, including production standups, continuous improvement initiatives, and those necessary to ensure smooth operation of the Quality Department and processes
• Work with appropriate stakeholders to disposition non-conforming materials, which may include coordinating rework with vendors or modification in-house

• Assessing product specifications and customer requirements to determine critical-to-function features and establish inspection sampling plans
• Manage compliance programs including Restrictive of Hazardous Substances (RoHS), Conflict Minerals, and Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), as well as Toxic Substances Control Act (TSCA), Cobalt, and customer-specific restricted substance programs
• Ensure the Quality Department operates in accordance with company safety policies
• Assist with the development of tests and procedures necessary to ensure quality product
• Identify and implement appropriate quality-related training for the quality team and make recommendations for appropriate quality-related training for the production team
• Complete/submit First Article Inspection (FAI) reports to ensure final product meets customer requirements

Qualifications/Experience:

• Excellent understanding of quality procedures and methods with a focus on continuous improvement
• Proficiency with computer systems and applications, preferably: ERP Systems, Microsoft Suite and Manufacturing Operations Management (MOM)
• Minimum of three (3) years of experience managing a quality department
• Experience with medical devices manufacturing and ISO13485 requirements
• Experience in implementing Quality Management Systems
• Highly knowledgeable about quality inspection techniques, quality management systems, RMA processes, and inspection tooling
• Bachelors degree and minimum three (3) years of experience in a manufacturing environment OR a minimum seven (7) years of experience in manufacturing environment
• Experience with manufacturing of high-mix electromechanical assemblies highly preferred
• Ability to deal with complex issues in a fast-paced setting
• Strong supervisory and leadership skills
• Highschool diploma or equivalent required