The Quality Manager will work to apply knowledge in the implementation of an integrated Quality Management System (QMS) to ensure full compliance and a continual product, process, and supplier improvement culture. This individual will work closely with all cross-functional teams to create quality strategies that support customer needs and overall business objectives. Work on and provide solutions to a wide range of difficult problems relating to the quality aspects of design, validation, and manufacture of medical devices. The Quality Manager serves as owner and administrator of several aspects of the quality system, including but not limited to supplier management, customer feedback, process control, internal audits, change management, and design control. This quality and compliance professional will be responsible for assuring conformance to product serve as the sites lead ISO Representative.
This position is subject to the International Traffic in Arms Regulations (ITAR) which requires U.S. person status. ITAR defines U.S. person as an U.S. Citizen or U.S. Permanent Resident.
ESSENTIAL JOB FUNCTIONS:
Plans, implements, and directs quality program consistent with ISO and AS9100 quality systems.
Maintains and communicates quality objectives complementary to corporate policies and goals.
Maintains a working knowledge of government and industry quality codes and standards.
Assist in daily quality related requirements on the shop floor; such as in process and final inspection of parts and assemblies.
Develops and directs internal audit program, customer audits, certification audits, and audits vendors/suppliers. Works to resolve issues and non-conformances found during audits.
Leads investigations of customer complaints and ensures that corrective actions are implemented in a timely manner. Communicates with customer as required.
Leads investigations of internal non conformance and ensures that root cause corrective actions are implemented in a timely manner and treated with the same importance as a customer complaint.
Leads efforts to reduce quality issues including corrective action, preventive action and supplier quality concerns.
Ensures purchases of materials meet customer requirements.
Works with Manufacturing and Quality Engineers in the preparation of Quality Data Packets.
Has active role on quality control team, leads team in document and data control.
Promotes a positive and professional work environment.
Leads and records company's quality management review meetings.
Serves as the liaison with 3rd party auditing and evaluation organizations.
Monitors the approved supplier and supplier evaluation processes.
Manages the process integrity/data collection processes and reporting to senior management.
Oversees the customer satisfaction and evaluation process.
Monitors laboratory processes and effectiveness.
Utilize six-sigma quality tools, when appropriate, to define, measure, analyze, improve and control processes and outcomes.
Responsible to maintain & support processes, procedures & K.P.I.'s owned by your position.
QUALIFICATIONS:
A bachelor's degree in industrial management, quality management or related field.: three to five years related experience and/or training; or equivalent combination of education and experience.
Demonstrate effective interpersonal and communication skills.
Experience with ISO and/or AS9100 quality systems, quality planning and mechanical inspection
Previous supervisory experience, quality function preferred.
Demonstrate organizational and analytical skills.
Ability to read and interpret documents, write reports and correspondence, and convey appropriate message to vendors, customers, and employees.
Demonstrate the ability to manage risk and resolve conflict.
Must be able to resolve complex manufacturing problems and troubleshoot manufacturing/production systems.
Ability to apply your knowledge of mechanical engineering, machining, metrology instrumentation and experimental techniques in developing customer solutions.
Experience and knowledge with ASME Y14.5.
Experience with PC DMIS
Experience with Epicor or other ERP system
Experience with special processes i.e., plating, welding, heat treat, etc.
Knowledge of CMM, and injection molding
Experience with Supplier Certification and Supplier Quality Planning
ASQ or similar professional certification
Working knowledge of quality improvement tools, including Six Sigma
WORK ENVIRONMENT:
This job operates in a professional additive manufacturing, traditional manufacturing and office environment. This role routinely uses standard office equipment such as printing equipment, computers, phones, photocopiers, filing cabinets, etc.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and listen. The employee frequently is required to stand; walk; use hands to handle or feel; and reach with hands and arms
Ability to accomplish the physical requirements of the position with or without reasonable accommodation
SAFETY AND POLICY PRACTICES:
Each employee must be knowledgeable of standard safety policies and procedures and adhere to the same while supporting the goals and objectives of the organization and recognizing the Company's need to achieve its business objectives. Each employee is responsible for complying with company hazardous waste disposal procedures.
AFFIRMATIVE ACTION:
The company is proud to be an Equal Opportunity Employer of Minorities, Women, Protected Veterans, and Individuals with Disabilities. All terms and conditions of employment will be administered without regard to an individual's sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected veteran status, or any other characteristic protected by applicable law.