Responsibilities of essential functions include:

1. Effectively communicate quality requirements to suppliers and internally act as the main point of contact with suppliers regarding quality issues
2. Review non-conforming products as a member of Material Review Board
3. Promote the use of quality tools and continuous improvement techniques internally to reduce variability, achieve process control and improve the overall quality of processes, systems and product(s)/materials
4. Develop positive relationships and effective lines of communication with suppliers (partnership- oriented)
5. Train suppliers to effectively implement and execute Supplier Corrective and Preventive Actions (SCAPA), Supplier Notification, change controls and root cause analysis
6. Prepare supplier audit schedule and conduct supplier quality system audit to ensure that supplier quality system/processes are compliant to agreed requirements and any applicable regulatory requirements
7. Collect, report, analyze and trend supplier quality data and performance metrics to create supplier ratings
8. Maintain supplier files including the Approved Vendor List, Quality Agreements, Quality Management System Certificates, Quality Surveys, Supplier Questionnaire, list of validation for different processes, Supplier Audit Schedule and Reports, Supplier Performance Assessment, etc
9. Recommend suppliers for qualification and/or disqualification based on overall quality performance
10. Evaluate supplier processes and collaborate with suppliers on process improvement
11. Ensure effective internal & external communication with Engineering, Operations, Quality, Regulatory and Procurement to identify opportunities for quality & productivity improvements and to ensure that suppliers are compliant to applicable regulation
12. Track status of any open SCAPA, supplier quality issue, supplier notification and communicate with supplier to work effectively to close out any open quality issue in timely fashion
13. Communicate with suppliers regularly to address any concerns and foster an environment that facilitates continual improvement in working relationship
14. Provide training in an effective manner

Responsibilities of non-essential functions include:

1. Inspect incoming materials and finished goods to technical drawings or product specifications by performing dimensional measurements, function tests and pattern assessments
2. Act as backup to Quality Manager
3. Maintain commitment to Quality Goals and Quality Policy

Requirements:

1. Quality management experience in a regulated industry or related experience required
2. Ability to solve problems effectively and efficiently required
3. Ability to lead and coach staff members required
4. Excellent written and oral communication, technical writing and editing skills required
5. Skilled at creating, analyzing and summarizing statistical data required
6. Proficient with Microsoft Office required
7. Ability to manage and prioritize multiple projects required
8. Ability to follow verbal and/or written instructions such as part drawings, traveler, work instructions, process specifications and direction from the supervisor in completing tasks effectively and efficiently required
9. Ability to conduct meetings with supplier(s) remotely through video conferencing required
10. Excellent liaison skills, internal and external communication skills required
11. Knowledge of manufacturing and production process required
12. Bachelor’s degree in Engineering or relevant technical field required
13. Travel within S. and/or internationally required
14. Knowledge of QSRs and ISO 13485, EU MDD, EU MDR, GMP and FDA 21 CFR preferred
15. Minimum of 3 years experience in supplier management preferred
16. ISO Lead auditor or ASQ/CQE certifications preferred
17. Ability to provide guidance to improve process efficiency preferred
18. Reliable and responsible
19. Organized, detail oriented, accurate, thorough
20. Outgoing, enthusiastic and persuasive
21. Proactive and able to make decisions
22. Works well under pressure and meets tight deadlines, maintains composure in challenging situations
23. Work independently with minimal to no supervision

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is occasionally required to stand; walk and sit. Specific vision abilities required by this job include ability to adjust focus. Lifting/carrying up to 30lbs.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

ADDITIONAL NOTES

ARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ARCH Global Precision are employed on an at-will basis.
This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.

A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.