Quality Assurance Manager
|Job Location:||Santa Maria, CA|
Young Innovations is a manufacturer and marketer of high-quality dental equipment and supplies. With an outstanding reputation for quality, our company has a broad portfolio of market-leading products across a variety of categories. Preat Corporation is a subsidiary of Young Innovations and is an aggressive, fast-growing, successful Dental Prosthetic Manufacturer and Supplier.
We are looking for a dynamic individual to join our team at Preat Corporation at our Santa Maria, CA facility. This position is responsible for the design and implementation of policies and procedures to ensure that quality standards are met or exceeded. They make sure that other employees are trained to understand quality standards and safety requirements. They are responsible for maintaining and updating all Quality Management System documentation.
- Accomplishes quality assurance objectives by training all employees on the Quality procedures and policy
- Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
- Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures.
- Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
- Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
- Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
- Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
- Establishes product quality documentation system by writing and updating quality assurance procedures.
- Maintains product quality by enforcing quality assurance policies and procedures and government requirements
- Contributes to team effort by accomplishing related results as needed
- Lead on any ISO, FDA or other Quality audit
- Improve existing processes and develops new processes to improve efficiencies
- BS/BA in science or technical field
- 5+ years of Quality Assurance experience with medical devices or pharmaceutical
- Previous participation in regulatory audits / FDA inspections
- Must be a team player with strong interpersonal skills who can organize work tasks to effectively complete projects and create win-win situations when possible.
- Must also work independently and take a hands-on approach to the work when necessary.
- Excellent written and oral communication skills, and capable of interacting with different functional groups within the business.
- Must be results-oriented and capable of managing multiple tasks in a dynamic environment.
- Office environment, with Sitting and Standing for long periods of time.
- Occasional exposure to manufacturing plant environment, with some abnormal variations in temperature, unavoidable fumes, noise, dust and atmospheric conditions.
- Periodic lifting or moving objects 40 lbs. or less.
- Ability to travel 10% or less. Visit sister facilities, trade shows, vendors, or customers to provide technical assistance when needed.
Preat/Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer