In this role, you will plan, schedule, execute & communicate all items regarding quality issues, complaints, validations & other projects to QA Senior Supervisor and Program Manager. Be a strong advocate for product, process, and system quality at all stages of product realization. Participate in steering committees which originate from both customer and manufacturing facilities. Support customer complaint data acquisition, root cause analysis, corrective action and complaint handling. Also perform all duties associated with the auditing and documentation of compliance related items against GMP and ISO standards.
location: Tempe, Arizona
job type: Temporary
salary: $38 - 40 per hour
work hours: 9 to 5
- Exhibit a strong "quality first" mentality and ensure that product and process quality are held to the highest standard.
- Conduct thorough root cause analysis and establish appropriate CAPA for product nonconformance.
- Review and approve product / process deviations or rework documentation.
- Provide quality reports and review trending on assigned areas of responsibility.
- Work independently and with project teams to develop design control deliverables including quality plans, manufacturing & inspection documentation, test methods, and any other necessary quality records.
- Participate in the development and maintenance of product risk and hazard analysis in accordance with ISO 14971.
- Meet company and departmental goals in the continuous improvement of all products, services and processes.
- Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer's experience.
- Work with management and technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.
- Maintain information and statistics on our site's quality performance on a monthly basis including the site's Cost of Quality data.
- Performs other duties as assigned based on business needs.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
- Exhibits regular, reliable, punctual and predictable attendance.
- Bachelor's in Science, Operations, or Business
- Experience: 3-5 years of experience
- Experience using Six Sigma & SPC tools and techniques
- Experience with drug handling and medical device regulations (21 CFR 210, 211, and 820)
- Experience with ISO 9000 and ISO 13485 standards and GMPs
- Excellent written and oral communication skills
- Excellent critical reading and writing skills
- Problem solving including root cause failure analysis methods
- Planning/organizational skills
- Computer skills required especially MS office applications and statistical analysis systems
- General understanding of manufacturing and plant operations
- ASQ certification (CQE or CQA)
- Green or Black Belt certification
- Chemistry or Engineering Degree
- Graduate degree
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
- Support and contribute in Lean Sigma programs and activities towards delivery of the set target
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.