Quality Director

POSITION SUMMARY

The Director of Quality is an Executive position responsible for oversight of Aved’s Quality Management System (QMS), Quality Department and Documentation. The Director reports to the Group President and provides leadership of the Company and Customer Quality requirements through Engineering development, New Product Introduction (NPI), Document Control, Supply Chain, Manufacturing, and Customer support to drive continuous quality performance. Responsibilities include continual Quality Management System (QMS) development, internal and external performance metrics, and compliancy with ISO9001, ISO13485, cGMP, and customer requirements.

ESSENTIAL FUNCTIONS

Evaluates Aved’s Quality Management System (QMS) from a strategic level to ensure that products and processes meet quality, integrity, functionality, and traceability standards.

• Collaborates with management and senior staff across production and materials departments to establish acceptable quality metrics.
• Develops and implements quality standard testing and evaluation processes:
  • Responsible for coordination of process/product validation including IQ, OQ, PQ, PFMEA, Risk Analysis, PPAP, and relevant Regulatory Compliance with cross-departmental support.
• Facilitates communication with internal and external stakeholders in quality management.
• Assesses yield results and collaborates with Engineering, Production, and Materials to improve overall Quality output.
• Reviews and owns quality control documentation such as checklists, logs, work instructions, and reports for effectiveness, accuracy, and relevance.
• Routinely reports status of Aved’s quality control and quality operations to executive leadership and, when required, regulatory agencies.
• Oversees staffing levels and resources to meet quality objectives.

POSITION QUALIFICATIONS

Excellent verbal and written communication skills with the ability to mentor staff.

• Thorough understanding of quality control standards and methodologies in manufacturing.
• Excellent organizational skills and attention to detail.
• Strong analytical and problem-solving skills.
• Strong supervisory and leadership skills.
• Decision Making - Ability to make critical decisions while following company procedures.

SKILLS & ABILITIES

Education: BA in Engineering or Quality Management

Experience: Eight to ten years of related experience required with at least five years as a quality manager or similar role highly preferred. Training in Six Sigma, Lean Manufacturing, IPCA610 and IPCA620 standards preferred.

Computer Skills: Microsoft Office Suite, Proficiency in database management and reporting