Manager of Quality, Safety and Regulatory Affairs

COMPANY SUMMARY:

Vergent Products (www.vergentproducts.com) is a dynamic and growing company in Loveland, Colorado that creates and produces electro-mechanical products while providing freedom for its employees to achieve their goals in an enjoyable environment. We offer our clients a broad range of services for product realization including product conceptualization, design, prototyping, regulatory certification, manufacturing, and warranty service.   
 

JOB SUMMARY:     

Responsible for leading the organization forward in all dimensions of quality, safety, and regulatory compliance including design, supply chain, manufacturing, and services.

Responsible to develop, implement and continuously improve the Quality Management (QMS), Safety Management Systems (SMS) and Regulatory Management System (RMS). 

Leads and manages a staff engaged in quality, safety, and regulatory functions.   

Leads cross-functional teams to meet quality, safety, and regulatory goals and objectives.   Functions as the principal client contact and champion for prevention and resolution of quality, safety, and regulatory matters. 

Acts as champion and principal educator for the advancement of proprietary and advanced quality, safety, and regulatory planning and methods.   
 

DUTIES AND RESPONSIBILITIES:

• Administer and improve the QMS, SMS, and RMS. Act as Management Representative to clients, suppliers, and agencies.  Ensures compliance to applicable internal and external requirements, including the implementation of policies, objectives, and goals.
• Continuously monitor the effectiveness of the management systems.
  • Function as Lead Auditor for internal audits.
  • Facilitates client, supplier, internal, and certification body audits.
  • Manages and drives the CAPA processes.
  • Facilitates internal metric reviews (trends, paretos, audits)
• Leads the development and improvement of a culture of quality, safety, and citizenship:
  • Develops and drives behavioral expectations and reinforcement systems.
  • Provides training and implementation leadership for:
    • Quality of Management: SWOT, Policy deployment
    • Design: Agile, QFD, Value engineering, DfX
    • Prevention: APQP, SPC, FMEA, MSA, PPAP, Verification & Validation
    • CAPA: Kaizen, SPDCA, Root cause analysis,
    • Manufacturing: 5S, theory of constraints, demand flow (DFT)
    • Service Excellence: employee engagement, client surveys
    • Citizenship: Ethics, Code of Conduct, RoHS, Conflict Minerals,
  • Promotes culture of quality in supply chain .
• Responsible for supply chain quality management including supplier qualification, supplier on-boarding, defect prevention, quality management, and supplier improvement strategies.
• Responsible for ensuring the collection and analysis of client experience data, including warranty events, and implementing preventative action.
• Responsible for establishing product quality design and workmanship standards while ensuring their deployment. Understand and facilitate relevant industry standards for quality (IPC, SPI, sheet metal, machining, etc)  
   

KNOWLEDGE, SKILLS, and ABILITIES: 

Experience in quality system and supplier quality management methods and quality control practices.

Ability to communicate with people within and outside the organization, and influence quality performance practices.

Demonstrated QMS auditing skills; lead auditor and safety system auditing skills preferred.

Strong electronic, electrical and electro-mechanical product design and manufacturing knowledge.

Ability to research operational systemic issues and generate appropriate and innovative solutions.

Ability to exercise independent judgment to ensure quality system effectiveness focused on business objectives/success.

Demonstrated ability to execute multiple projects simultaneously and independently, and meet project and initiative goals, objectives and deadlines.

Exceptional written and verbal communications skills; demonstrated ability to develop QMS documentation that is concise and applicable to operational requirements.

Proven ability to focus the management systems on applicable and changing requirements of the organization.  
 

EDUCATION AND EXPERIENCE:

Bachelor’s degree in an applicable technical, industrial or manufacturing discipline, or an equivalent combination of education and experience.

Ten years experience in a technical manufacturing environment, including a minimum of 2 years of experience in quality engineering or quality management functions.

Experience as a management representative responsible for facilitation of ISO certification body auditors required.

Lead auditor/assessor experience in ISO 9000 or ISO 13485 (preferred) quality management systems; formal training in ISO quality system auditing highly preferred.
   

KEYWORDS:
 

Vergent Products is an Equal Opportunity Employer.
Submit resumes and cover letters to hr@vergentproducts.com