The core purpose of this role is to provide support to Arrow Electronics, Phoenix, AZ working to manage end-to-end ISO13485 & FDA processes.
What You'll Be Doing
- Maintain and improve quality system through database management and analysis of quality data to various quality certifications and standards.
- Monitor and audit processes and make improvements in quality where necessary to assure standards are being met. Works with other departments to identify and resolve quality issues. Provides Corrective Action when quality issue arises.
- Manage the quality assurance department activities within the site. Maintain and continually improve the quality system, using data to define opportunities for improvement. Drive process improvements. Maintain ISO certifications
- Manage control of the documentation process, the internal quality audit and inspections systems, and the calibration system.
- Work with other departments to maintain statistical process control of the site's processes.
- Maintain and improve Field Quality Report (FQR) customer complaints system.
Along with other department heads, drive compliance to the annual Business Plan's key metrics.
- Interface with external customers regarding quality issues. Assure prompt resolution to issues.
- Train applicable workers on Quality- related areas, such as 5S, Lean, SPC, etc.
- Participate as the Quality Representative on all Product Development/Design Transfer product.
- Advocates and fosters communication channels with other technical resources internally & externally (i.e. Customer, Suppliers & Processes).
- Lead the creation & implementation of Quality Assurance Plans, Process Controls, Control Plans, Validation Activities, PFMEA's.
- Lead the Risk Assessment Evaluation Process within NPI to ensure all new Risks are mitigated to an acceptable level as part of the product/process development requirement.
- Work with suppliers in gathering support documentation for processes that will be performed on new products (Process Routers/build plans, Control Plans, Risk Assessments, Process Validation Reports.)
- Identify measurement requirements at each phase of the manufacturing process and determine gaging methodology and frequency for all print dimensions.
- Participate in Product/Pilot Reviews. Identify non-conformance trends and develop technical investigation plans. Investigates and analyze supplier(S), Customer(s) and Internal complaints and non-conformances.
- Complies and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
- Develop & Perform Quality Analysis methods such as (GR&R's, Capability Studies, Fault Tree Analysis).
What We Are Looking For
- College Degree Preferred (preferably in a technical field).
- This position requires 5 plus years of relevant quality experience. Experience with Medical Device manufacturing is considered a plus. Experience with advance product quality planning as well as problem solving is required.
What's In It For You
At Arrow, we recognize that financial rewards and great benefits are important aspects of an ideal job. That's why we offer competitive financial compensation, including various compensation plans, and a solid benefits package.
- Medical, Dental, Vision Insurance
- 401k, With Matching Contributions
- Generous Paid Time Off
- Health Savings Account (HSA)/Health Reimbursement Account (HRA) Options
- Growth Opportunities
- Short-Term/Long-Term Disability Insurance
- And more!
Arrow is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, gender, sexual orientation, gender identity, national origin, veteran or disability status. (Arrow EEO/AAP policy)
US-AZ-Phoenix, Arizona (East Sky Harbor Cir)
This job has expired.