What are the responsibilities and job description for the Quality Assurance Manager position at Shimadzu U.S.A. Manufacturing, Inc.?
Essential Functions:
1. Identifies and maintains needed documentation for all processes necessary for the QMS and EMS.
2. Facilitates the determination of process ownership.
3. Acts as the Management Representative for the QMS and EMS.
4. Ensures that standards for SUM Standards/Certifications are met. (Example: ISO and FDA/QMSR).
5. Coordinates and manages ISO 13485, 14001, and FDA audits.
6. Acts as the primary communicator in communications with the FDA.
7. Determines compliance with all QMS, EMS, and regulatory requirements. Responsible for aggressive internal audits to determine QMS and EMS compliance.
8. Verifies necessary training of personnel is complete to comply with the QMS and EMS.
9. Communicate with customers and/or vendors as required to ensure compliance with the SUM QMS.
10. Acts as primary contact for customers as it relates to quality issues, advisory notices, recalls.
11. Promotes Continual Improvement, validation, and preventive projects to increase production efficiency and maintaining product Quality as the primary focus.
12. Manages Document Control, quality assurance Engineers/Inspectors, the Engineering change notice (“ECN”) team, calibration function, and regulatory Engineers involved in compliance with RoHs, FDA/QMSR, ISO, NRTL, etc.
13. Represents the company within and outside the Company.
14. Recommends and initiates personnel actions such as hiring, promotion, coaching, discipline, transfers, administering pay changes, training and terminations.
15. Approves any absences or overtime.
16. Assist workers in solving work problems.
17. Orients and trains new workers
18. Initiates plans to motivate workers to achieve goals.
19. Maintains compliance with all human resources dictated requirements.
20. Assists team members with various tasks.
Secondary Functions:
1) Provides a safe and clean work environment for employees.
2) Performs other duties as assigned.
Job Scope/Demands & Complexity:
1) Frequent new and varied work situations.
2) Job involves a high degree of complexity with respect to regulatory issues and can be demanding when a variety of situations occur at once.
3) Operate from established and well-known procedures, with the ability to use discretion in dealing with situations outside of the norm.
4) Operate independently and perform duties with limited direction given.
Accountable for:
a) long-range operational and strategic planning
b) preparation and administration of the quality department’s budget.
Supervisory Responsibility:
Position provides supervision and daily work direction to quality assurance department employees.
Interpersonal Contacts:
Contacts will be:
1) Internal regular communications Assembly, Procurement, and Planning.
2) External Communications to include
- Customers.
- Vendors.
- Regulatory agencies.
- Other departments or representatives from corporate headquarters and sister companies with others or independently.
- Contain discussion of confidential and sensitive matters, face to face, telephone, e-mail and other written.
Knowledge, Skills & Abilities:
1) In-depth knowledge of ISO requirements
2) Knowledge of the FDA’s QMSR codes, specifically 21CFR, Section 820
3) Rudimentary understanding of other countries’ regulatory standards such as the European Directives i.e. the Medical Device Directive (MDD), Canada’s CMDCAS regulations, and Japan’s PAL regulations would be useful and a plus.
4) Knowledge of electronics, assembly, sheet metal fabrication and machining of parts
5) Decision-making and use of discretion
6) Solve problems while using creativity, analytical thinking and independent judgment and/or action.
7) Competency in computer systems, manufacturing software (Syteline preferred), MS Office software package (Word, Excel, Teams, Outlook, Powerpoint).
8) Ability to facilitate the use of supply systems, such as ERP/MRP, as tools for analysis.
9) Supervise, train and mentor team of employees.
10) Make presentations and provide input into company operations.
11) Ability to implement ISO 13485, 14001, and FDA/QSR standards.
12) Maintain flexibility within an international corporation.
13) Perform advanced math (analysis, statistics, significant data or number manipulation)
14) Strong knowledge of statistical techniques and applications
15) Work independently and as a member of a team.
16) Communicate effectively and understand, read, write, and speak English.
17) Treat others respectfully and exhibit good interpersonal skills.
18) Make routine decisions effectively.
19) Ask for guidance and assistance where needed.
20) Meet deadlines and production goals.
21) Prioritize, and handle multiple, concurrent projects or assignments.
22) Follow all policies, procedures and guidelines.
23) Work effectively with coworkers, supervisors, and all working contacts.
Job Conditions:
Normal office conditions with occasional exposure to production/warehouse environment.
Extensive computer work.
Working a minimum of 40 hours per week is expected, but work volume may require working more than 8 hours per day or 40 hours per week to complete essential duties of the job.
Travel domestic or internationally as required. Must have a valid passport or the ability to obtain a passport.
Physical Requirements:
Constant: Sitting, talking, hearing/listening, repetitive use of hands, wrists and fingers for writing and keyboarding. Occasional: Walking, standing, bending, reaching, lifting and carrying 35 lbs. or less. Visual acuity to be able to read printed documents and computer screens.
Education & Experience:
1) Bachelor’s degree in business or engineering or related field - Required.
2) 8 years of related experience in quality discipline in a manufacturing environment, medical systems - Preferred.
3) 5 years supervisory/management experience and leading a manufacturing, and/or engineering organization. - Preferred
4) Experience with Environmental Management Systems - Preferred.
5) Familiarity with Japanese culture and language is a significant plus.
General Position Summary:
The Quality Assurance Manager (QAM) will ensure that the SUM quality management system (QMS) and the SUM Environmental Management System (EMS) are in compliance with the requisite codes and regulations. QAM will report to the management team regularly on the organization’s compliance with the QMS and EMS and any opportunities for improvement of compliance. As a member of the management team, provides the company with leadership and establishes company policies.