Quality Assurance Manager

Description

The Quality Assurance Manager is responsible for?ensuring that each part of the manufacturing process has been validated and is conforming to specifications. This position is to?provide leadership and direction to the quality team by developing, managing, implementing, and improving Quality Management Systems and processes. You will play a vital role in moving the company forward to be a leader in the industry.

Requirements

Key Job Responsibilities

• Manage the daily activities of the Quality Department to meet established goals and objectives.
• Act as the primary quality representative for existing and new products. Leads and develops all aspects of the Quality Assurance function within the manufacturing processes.
• Review and approve all quality documentation related to products, including validation reports, product test protocols, change management and notification processes, corrective and preventative actions (CAPA), customer complaints, audits, and related items.
• Develop and manage implementation of all policies, procedures, and work instructions to ensure organizational compliance with all internal and external customers.
• Identifies and mitigates risk from within predetermined parameters and ensures that issues are escalated to applicable management. Apply a risk-based approach to decision-making, guidance, and issue mitigation.
• Work with each department within the organization to ensure compliance with the company's corporate electronic Quality Management System (eQMS)
• Effectively collaborates with departments (i.e. Engineering, Manufacturing, Supply Chain) on various projects/improvements when input/participation from Quality is needed
• Lead improvement initiatives.?Monitor and report on key performance indicators.?Manage and support the internal and external audits.
• Review, and maintain supplier and customer Quality Agreements in conjunction with Supply Chain and Sales.
• Oversee Supplier approval process and internal training metrics.
• Perform regular meetings with the teams to drive performance improvement and increased levels of engagement geared toward achieving greater customer satisfaction and reduce customer complaints and non-conformances.
• Build a strong, trusted, and influential relationship with all departments in the organization.
• Other duties as assigned and required to support the business objectives. Support all sites as needed and directed with above activities
  
  

Education, Skills And Experience Requirements

• Bachelor's degree in Engineering or a related field is required
• 5-7 years of previous experience in a Quality Assurance leadership role is required for this position, previous life sciences or med device experience is strongly preferred
• Working knowledge of ISO 9001 is required, ISO 14001, 45001, 13485, and other industry regulatory knowledge are highly desired.
• Fluent with traditional and current Quality management tools and practices. Attention to detail is a must
• Experience utilizing Six Sigma and/or Lean Manufacturing methodologies is highly preferred.
• Computer skills and proficiency with Microsoft Office software (e.g., Excel, Word, PowerPoint, Outlook).
• Excellent organization skills. Ability to handle multiple priorities.
• Ability to communicate effectively with all levels of the organization and with an outside customers.
• Demonstrated ability to set priorities, meet deadlines, and deliver commitments on time in a fast-paced environment.
• Ability to handle high-stress situations.