Quality Manager

The Quality Manager plans, implements, and manages quality assurance activities in support of the company Quality Management System (QMS) goals and objectives. This includes, but is not limited to, support and participation in product development activities; manufacturing support including oversight of incoming, in-process and final inspection activities; development, maintenance and reporting of quality metrics including trend analysis, statistical analyses and statistical process control (SPC) as required. The function also includes root cause analysis in support of failure investigations and the ability to clearly communicate investigation findings and corrective actions to internal and external personnel including vendors, customers and customer quality inspectors. The function includes direct supervision and training of quality assurance technicians and inspectors, and management of metrology and related standards for calibration.

• Support the CARE values of the organization.
• Commit to producing a quality product for our customers.
• Lead and coach quality department team to drive a high performing culture.
• Ability to evaluate current state practices and analyze gathered data to identify opportunities for continuous improvement.
• Conduct periodic internal reviews or audits to ensure that compliance procedures are followed and investigate issues.
• Responsible for scheduling and leading all customer and regulatory audits.
• Track corrective and preventative actions identified within audits, work with various units for completion and submit responses to agencies/customers when required.
• Conduct off-site audits of third parties and vendors with detailed report of findings.
• Prepares and submits weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities.
• Assists in developing policies and procedures related to QA.
• Assist CAPA teams, and other project teams, in the development of action plans and implementation schedules, and the verification of completed actions.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in business, Industrial Engineering and/or mechanical engineering.
• Minimum 5 years prior experience in Quality Assurance
• Ability to effectively communicate and lead.
• Ability to multi-task and prioritize.
• Minimum 2 years directly related experience supporting compliance in a quality/compliance/ function /applicable compliance field.
• Knowledge of QMS and CAPA related tools or systems is required.
• Experience with inspections and inspection readiness activities and audits required.
• Flexible and able to adapt to company growth and evolving responsibilities.
• Strong project management skills: MS Word, Excel, PowerPoint
• Highly ethical, self-motivated and self-directed; works effectively independently as well as in a team environment.