In this role, you will direct and oversee the Quality Assurance functions in the greater Phoenix area in order to assure that quality and local and external regulatory requirements are met for contract manufacturing, as well as, proprietary medical device divisions.
location: Tempe, Arizona
job type: Permanent
salary: $145,000 - 150,000 per year
work hours: 9 to 5
- Responsible for the Quality Assurance function for the Arizona based medical device/contract manufacturing facilities
- Ensures the promotion of awareness of applicable regulatory requirements and Quality Management system requirements throughout the organization.
- Ensures that the processes needed for the Quality Management System are established, implemented and maintained.
- Contributes to the achievement of company objectives by playing an active role in the strategic planning process including the development of quality targets for continuous quality improvement.
- Defines quality objectives and functional responsibilities.
- Monitors progress of the Quality KPI's and communicate it to the organization and senior management.
- Interfaces with the manufacturing organization to analyze the effectiveness of the Quality Management System.
- Develop and implement strategies to increase performance against identified KPI's, reduce the Cost of Poor Quality, and improve product performance.
- Contributes to the quality improvement efforts of the company by following a structured continuous improvement approach, and focusing on root cause identification and correction.
- Oversees FDA and ISO inspections and any external audits/assessments to ensure that the facility Quality Management System is properly represented.
- Actively Interface with customers for quality issues, technical information, specification, agreements, audits, etc.
- Communicates with customers, attends customer governance meetings, attends customer audits, builds and strengthens customer relationships
- Manage the customer satisfaction processes and provide instructions when discrepancies are identified to improve overall customer satisfaction.
- Engenders cooperation between teams to enable issue resolution
- Serves as a facilitator and mentor to subordinates and fellow co-workers, retain/build organizational talent.
- Support global Material and Supplier Qualification processes. Evaluate the change notification associated with all relevant changes and collaborate with other departments or sites to evaluate and effectively implement the changes in a timely manner.
- Support Corporate, Supplier and local quality audit programs. Ensure that the audit programs are maintained as required by internal policies and procedures.
- Supports corporate QA/RA functions.
- Other duties as assigned
- Bachelor's in engineering or closely related field
- A minimum of 10 years of relevant professional experience in the medical device or pharmaceutical industry, preferably in a Manufacturing/Distribution environment
- Attention for detail and deadline driven
- Ability to interface with and effectively communicate with a broad range of customers, cross functional teams, as well as executive management.
- Excellent computer skills, experience with MS Office, ERP systems, Statistical software, etc.
- Proven experience in establishing procedures for maintaining high standards of product quality and reliability
- Professional communication and presence
- Strong knowledge of FDA and international regulations
- Proven ability to effectively contribute to the quality improvement efforts of the company
- Excellent implementation and customer service skills
- Master's Degree
- Medical Device/Pharma industry
- Quality Engineering/Lean/Biomedical auditor certification
- Contract Manufacturing experience - 5+ years
- Able to be aware of all relevant SOPs as per Company policy
skills: Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.