Director of Quality, Regulatory & Improvement
Key details
- Location
- Bloomfield, CT, United States
- Work style
- Onsite
- Level
- Lead / Staff+
- Job type
- Full-time
- Experience
- 10–13 yrs
- Function
- Legal & Compliance
- Focus area
- other
- Posted
- 12h ago
Skills
auditingcomplaint handlingdata acquisitiondesign controlsdesign of experimentsdmaicgage r&riso 13485iso 9001kpismanufacturing processesppapprocess controlproject managementquality assurancequality auditsquality controlquality managementquality management systemssix sigmaspcstatistical analysisword processing
About the role
Title: Director of Quality, Regulatory and Improvement
Job Summary:
This senior leadership role leads the quality departments for all Deringer-Ney locations globally. The Director implements best practices and metrics to coordinate all teams under a unified Quality Management System and is responsible for ensuring that the company's products, services, and manufacturing processes comply with strict government laws, industry standards, and internal quality systems. The role plans, coordinates, and directs the activities of the quality assurance and compliance programs to ensure the production of consistent, reliable products that meet or exceed established standards, and leads the continuous improvement team to support, train, and execute the DNIOS system.
Supervisory Responsibilities: Yes
Duties/Responsibilities:
- Manage all quality departments by formulating, developing, and overseeing global goals, objectives, policies, procedures, systems, and outcomes pertaining to quality controls, assessments, and audits.
- Quality Management Systems (QMS): Build, maintain, and continuously improve QMS frameworks (such as ISO 13485 and ISO 9001).
- Develop a high-performance team by acquiring, developing, training, coaching, cultivating, and managing talented Quality Control personnel.
- Maintain and improve the quality system through routine system audits and corrective actions, and ensure that corrective actions, whether internal or external, are handled in a timely manner.
- Risk & Lifecycle Management: Oversee design controls, validation packages, complaint handling, and post-market surveillance (such as Automotive Reporting).
- Manage and maintain quality inspection and product release programs for raw materials, work in process (WIP), and finished goods.
- Regulatory Compliance & Filings: Lead product submissions and act as the primary liaison during agency audits.
- Disseminate quality awareness, adherence, and developments to global stakeholders by scheduling and performing regional quality audits and by ensuring that ISO systems are managed and maintained.
- Serve as an active member of the DNI Leadership Team, sharing the function's progress toward its goals while setting, and driving toward, an aspirational vision for a best-in-class quality department.
- Create a Cost of Poor Quality metric for the organization and set specific goals to improve quality performance across the company.
- Lead the development of the Annual Strategic Planning (P.D.C.A.) Cycle to include the Improvement Process.
- Lead the organization in attaining key metrics based on Balanced Scorecard (BSC) Objectives. Understand the department's key performance indicators and leading and lagging indicators, and contribute to achieving these goals, both individually and as a team.
- With the CIP Team, perform systematic audits designed to confirm that process standards are being utilized and met (BSC One-Page Reports).
- Interact with and make recommendations and presentations to the Executive Leadership Group via standardized checks: weekly, monthly, quarterly, and year-end. Maintain the PDCA Cycle while focusing on BSC Objectives.
Required Skills/Abilities:
- Strong background in ISO 9000 system management, including training and auditing.
- Strong background in ISO 13485 system management and thorough knowledge of FDA requirements and other international standards that regulate the medical device industry.
- Knowledge of automated inspection equipment, including vision systems and coordinate measuring devices.
- Adept at delegating and managing multiple tasks with various levels of priority.
- Excellent communication skills; must be able to present ideas, results, and requirements effectively throughout the organization and to the customer on a timely basis.
- Expert skill set in applied statistics, reliability, design of experiments, MSA, GR&R, and project management.
- Fluency with various software packages commonly used in project management, database, SPC, word processing, and data acquisition.
- Analytical, problem-solving, project management, facilitation, and decision-making skills are essential.
- Strong leadership skills with the ability to motivate, coach, resolve conflict, and promote teamwork.
- Ability to see and hear the facts from several viewpoints while promoting success through interactive problem solving and teamwork.
Experience & Education Requirements:
- Technical degree (BS, BSE, or BSME) with a minimum of 10 years' experience in quality engineering or quality management.
- Strong preference for relevant industry experience in a metals or electrical connectors company or similar.
- 10+ years of progressive experience in Quality Assurance, Quality Control, or Regulatory Affairs within a regulated field such as medical devices, automotive, or defense.
- Preferred certifications: Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), or Certified Quality Engineer (CQE).
- Demonstrated project management skills in the areas of process control, SPC, automotive PPAP submission, and statistical analysis.
- Lean Green Belt or Black Belt certification, Six Sigma, and DMAIC process experience.
- Actively continuing training through courses and seminars.
Physical Requirements:
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift 15 pounds at times.
- Must be able to access and navigate each department at the organization’s facilities.
- Travel to other locations as required.
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