Avalign designs, manufactures, and delivers the highest quality, precision-machined tools and implants for a wide variety of surgical and medical specialties around the world. From proprietary implant coatings to German-made instruments, Avalign is a leading full-service manufacturer known for consistent and sophisticated production and supply chain management. Avalign Thortex's asymmetric porous coating on implants provides patients with more stability and less healing time.
Responsible for support of operations to ensure quality and operational goals are met. The Quality Engineer will utilize an engineering approach to improve manufacturing efficiencies and ensure the quality of all products.
- Participate as the Lead Quality Representative on all New Product Development/Design Transfer product.
- Advocates and fosters communication channels with other technical resources internally & externally (ie: Customer, Suppliers, Other Avalign Divisions).
- Lead the creation & implementation of Quality Assurance Plans, Process Controls, Control Plans, Validation Activities, PFMEA’s.
- Identify and procure any necessary gaging needed for new product.
- 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 Sub-Tier suppliers in gathering support documentation for processes that will be performed on new products (Process Routers, 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 Review Boards. 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).
EDUCATION AND EXPERIENCE
· 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. Experience in Gaging Methodology and Geometric Tolerancing & Dimensioning a plus.
Job Type: Full-time
Pay: $96,000.00 per year
- 401(k) matching
- Dental insurance
- Disability insurance
- Employee assistance program
- Flexible schedule
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
- Day shift
- Monday to Friday
- quality engineering: 5 years (Required)
- Personal protective equipment provided or required
- Social distancing guidelines in place
- Sanitizing, disinfecting, or cleaning procedures in place