Quality Assurance Manager

Description

Essential Duties and Responsibilities

• Accountable for effective integration and execution of company and customer, quality assurance and quality control (QA/QC) requirements in new product development, process validation/verification, production, storage and distribution of product   
• Creates product quality plans, in collaboration with the customer, when applicable.
• Leads production risk analysis and mitigation program, including but not limited to PFMEA.
• Coordinate quality department resource assignment to optimize and assure product quality throughout the project timelines and lifecycle.
• Identify and recommend metrology equipment and personnel needed to fulfill new and existing product/project requirements.
• Manage metrology/inspection team.
• Ensures that team members are meeting inter-departmental goals and timelines, as well as, working with Production team in meeting quality goals.
• Conducts management and employee meetings regarding quality related customer issues, production issues and procedures related to quality that directly relate to customer requirements.
• Ensures staff and employees have a clear understanding of all customer quality requirements.
• Reviews technical problems and procedures of all departments and recommends solutions to problems or changes in procedures.  
• Accountable for customer interface with quality aspects of: product qualification, quality planning and specification compliance related matters.  Assigns Quality Engineering staff as appropriate.
• Collaborates with all department managers and senior staff to ensure the quality program is running efficiently and effectively.
• Responsible for the Quality Management System (QMS) maintenance and development.  Lead, support and delegate quality system improvement programs and initiatives.  Maintain QMS certifications. Ensure the promotion and awareness of regulatory and customer requirements throughout the organization.
• Quality Management System Management Representative.  Manage internal and external quality system audits and communicate results to team.  Lead and coordinate observation corrective action.
  • Primary interface with regulatory auditors
• Maintain trend analysis on key quality system effectiveness metrics.  Inform plant leadership team of trends, propose and coordinate action to prevent adverse trends development and improve performance.
• Schedule and conduct site Management Review Meetings.
• Owner of corrective and preventive action (CAPA) system.   Track CAPAs for timeliness of completion, implementation and effectiveness.
• Work with plant leadership team to establish operational objectives and goals. Monitor progress to ensure goals are achieved.
• Owner of complaint management system. Track, assure resolution, and respond to customer complaints or customer satisfaction issues.
• Owner of ERP quality modules, responsible for content and content maintenance.
• Owner of Document Control/Management System, including: specifications, engineering changes, quality records, QMS documents, etc.
• Owner of equipment calibration and maintenance.
• Accountable for procedural compliance with facility and manufacturing pest controls, environmental controls and microbiological analysis and control.
• Lead and manage quality management system team project meetings, delegate tasks, prioritize activities and manage resources.
• Lead and manage direct reports while fostering personnel development.
• Other duties as assigned by Plant Manager and Director of Quality

Qualifications

Required Competencies, Skills and Experience

• Personal knowledge and experience with regulatory compliance, Audits, CAPA Submissions and IQ, OQ, PQ submittals.
• Excellent problem solving & root cause analysis skills are required.
• Interpersonal communication and project management skills a must
• Strong leadership skills that inspire team confidence and respect while motivating team members in a creative and effective manner
• Must have a desire for achieving excellence in customer satisfaction, process and product quality and reliability
• Strong understanding of ISO 9000, ISO 13485 and FDA QSR/cGMP quality standards.
• Must be extremely detail-oriented with respect to documentation and communication

Education and Job Experience Requirements

• Minimum 7 years of proven experience in a Quality Management role, responsible for overall Quality Systems in the Medical Device industry, or other highly technical, regulated products (aerospace, automotive, etc.).
• Plastics experience preferred
• Understanding of statistics required
• Six Sigma certification preferred
• BS degree in engineering required
• MS Degree a plus

Work Environment and Physical Demands

The work environment and physical demands detailed above are representative of those encountered while performing the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification.  They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.  All personnel may be required to perform duties outside of their normal responsibilities from time to time as needed.

Salary : $125,000 - $155,000