Director of Quality and Regulatory Affairs

Elma, New York


Employer: Procom
Industry: Technology
Salary: Competitive
Job type: Full-Time

On behalf of our client, Procom Services is seeking a Director of Quality and Regulatory Affairs.

As the Director of Quality and Regulatory Affairs, you will play a crucial role in the success of the organization by ensuring product quality and compliance. Your responsibilities will include setting departmental directives, procedures, and systems, as well as driving overall organizational performance. You will make key decisions and develop strategic plans to adapt to technological, product, or process changes.

This role is pivotal in continuously improving management systems to ensure all products and services meet regulatory, customer, and company standards. You will employ Lean and Six Sigma methodologies to lead and support production initiatives. Additionally, this role involves managing quality systems, directly communicating with customers about quality issues, and collaborating with other departments for compliance.

This position demands a seasoned leader with a proactive approach to problem-solving and a capacity for systems thinking. Experience with risk management methodologies such as AS9100, along with strong customer interaction skills, are also critical.

Director of Quality and Regulatory Affairs Job Details

• Management Representative - Serve as the primary contact for voluntary and compulsory regulatory compliance (e.g., CFR, ISO, AS).
• Leadership - Ability to motivate and influence others, acts as coach, mentor and teacher, provide support for issues which impact the customer. Acts as project and business leader, identifies, implements and acts as champion for new systems, methods, procedures. Ability to work effectively in decentralized business.
• Interpersonal Skills - Ability to articulate ideas in verbally, in writing, and orally. Strong presentation skills. Creates environment of responsible decision making.
• Problem Solving - Coordinate and manage resolution of problems using advanced statistical and problem-solving methodologies as defined by internal and external customers
• Compliance - Identify, develop, and establish systems to enable company-wide compliance with all applicable regulations both voluntary and compulsory. Collaboratively support manufacturing operations and continuous improvement efforts while maintaining compliance.
• Business Acumen - Demonstrates a solid understanding of entire business operation. Sponsors technologies and processes with the potential to redefine the customer relationship. Recognized as being able to originate and execute successful programs that have major impact on business objectives. Supports business operational objectives.
• Perform other duties as required.

Director of Quality and Regulatory Affairs Mandatory Skills
• Technical Bachelor's Degree (required); Professional Certification, MBA or Technical Master's Degree (preferred).
• Must have at least 12 years' experience progressive managerial/leadership experience in Aerospace Industry (or other highly regulated industry such as Automotive, Medical Device, or Pharmaceutical) and experience with discrete parts manufacturing.
• Holds certification by the American Society for Quality (or similar), Certified Six Sigma Black Belt, Certified Quality Manager, or Certified Quality Engineer (strongly preferred)
• Ability to interpret and communicate engineering requirements of customers and read drawings.
• Knowledge of Military Standards or other relevant industry standards (preferred)
• Ability to create a compelling strategic vision for the Quality function that spurs sustained organizational action.
• Effective leader with ability to mentor and develop members of the QA/RA team through coaching and effective performance management.
• Proven ability to create culture of accountability and ownership.
• Proven track record with establishing and maintaining strong internal and external partnerships.
• Must be able to work effectively at all levels in the organization and with external partners.
• Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders.
• Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects.
• Highly independent and self-motivated and integrates well within a team.
• Strong proficiency in Outlook, Word, Excel, and PowerPoint programs.
• Occasional evenings and weekends may be required.

Director of Quality and Regulatory Affairs Desired Skills
• Knowledge of Military Standards or other relevant industry standards.
• Professional Certification, MBA or Technical Master's Degree.

Created: 2024-08-22
Reference: FdxkbgAc8YQY
Country: United States
State: New York
City: Elma


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