SUMMARY

Under indirect supervision of the Director of Quality and Manufacturing, assume responsibility for day-to-day development and management of all activities and functions related to the quality system; determining the most efficient and effective implementations of quality processes; monitors, organizes and trains the auditing activity companywide; and performs related work as required. Manages Quality Department personnel: Quality Engineers, Quality Technicians, Etc.

PRIMARY DUTIES AND RESPONSIBILITIES

This list of duties and responsibilities is not all inclusive and may be expanded to include other duties and responsibilities as management may deem necessary to meet the needs of the organization from time to time, as needed.

Quality System Management

1. Manage and ensure conformance to appropriate international/national standards (such as ISO) and regulations (such as FDA QSR).
2. Manage product safety certifications (e.g. UL, CE, ETL, CCC, TUV) and other product regulatory requirements (e.g. RoHS, REACH, MSDS/SDS etc)
3. Management review
4. Designated management representative for the quality system with customers, vendors and all quality auditors (including regulatory bodies).
   • Ensures that quality processes are established, implemented and maintained
   • Reports on the performance of the quality system and need for improvement
   • Ensures the promotion of customer requirements
5. Corrective action process
6. Continuous improvement process and quality metrics
7. Non-conforming material process
8. Responses to customer complaints
9. Quality reporting to customer specifications
10. Supplier audits
11. Customer quality audits
12. Interact regularly with customer quality personnel
13. Must be extremely organized and highly responsive
14. Able to work closely with cross functional activities throughout the organization
15. Take ownership of quality issues and drive them to success.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requires minimum of a Bachelor’s degree and three to five years of prior work experience, preferably with familiarity with the CMQ/OE body of knowledge, including the implementation and execution of an ISO quality system in a manufacturing environment. Auditing and Management experience preferred. CMQ/OE or other appropriate certifications (e.g. CQA) a plus. Product safety certification knowledge preferred.

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

• Skills and knowledge areas: understands basic ERP/MRP/PLM concepts, ISO 9000 based QMS requirements, root cause analysis and corrective action concepts.
• Must be familiar with Microsoft Windows and Office software. Experience with PLM (such as Agile or Arena) and ERP (such as NetSuite or Epicor) software preferred.
• Requires good oral and written communication skills in order to interact professionally and courteously with other Associates, vendors, and customers.
• Preferred knowledge of typical computer components, computer building, calibration activities, and software validation. Preferred supplier management experience with sheet metal, PCB, and cabling suppliers.
• Possesses the ability to lead and motivate groups and individuals. Able to think creatively and strategically to successfully mediate and negotiate with individuals and groups internally and externally. Able to overcome obstacles to cooperation and foster harmonious relations.
• Strong project management skills. Able to balance competing priorities, complex situations, and tight deadlines.
• Must be able to simultaneously direct several functions within the organization to achieve concurrent assignments often with competing deadlines and resource requirements.
• Is able to quickly identify obstacles or potential obstacles and then creatively and effectively remove or minimize the obstacle.
• Able to cultivate a culture of teamwork within and between functional groups inside and outside the organization
• Provide assistance to other engineering projects and departments as assigned.
• Must be extremely adaptable to changing requirements.

PHYSICAL REQUIREMENTS AND WORKING CONDITIONS

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The phrases “occasionally,” “regularly,” and “frequently” correspond to the following definitions: “Occasionally” means up to 1/3 of working time, “regularly” means between 1/3 and 2/3 of working time, and “frequently” means 2/3 and more working time.

Must possess mobility to work in a standard office and lab setting and to use standard office equipment, including a computer, and to attend meetings at various sites within and away from the office. Occasionally required to lift and carry materials weighing up to 80 pounds. Must have vision to read printed materials and a computer screen. Requires hearing and speech to communicate in person and over the telephone. Occasionally required to travel domestically and internationally. This position is factory based, in Mequon, WI.