Senior Quality Engineer

Orchid•Oregon City, OR

20d•Onsite

About The Position

The Senior Quality Engineer supports the ongoing quality of Orchid's legacy products across all sites by focusing on a strong relationship with critical customers, working with project management and manufacturing engineers to support new product introductions and ongoing validation, and planning and executing training based on business needs. The Oregon City, OR Site was established in 1969 and joined the Orchid team in 2012. The site focuses primarily on investment casting and 3D wax printing and machining and finishing and coating of orthopedic implants for extremities and large joint markets. Robotic wax assembly, internal tool and design, finished machining, polishing, and sintered bead coating are key capabilities of the site. Our 80,000 square foot, FDA registered site employs approximately 175 team members. We ship nearly 1 million hip and knee joint implants to our customers who, in turn, provide solutions that enable patients to live longer, active lives. Fully integrated, our site manufactures medical implants from start to finish complying with the ISO 13485:2016 standard.

Requirements

Bachelor of Science (B.S) (Required)
5+ Years of Experience (Required)
Operational Functions - Extensive Experience
Quality Management - Extensive Experience
Manufacturing Safety - Extensive Experience
QSR and ISO - Extensive Experience
Information Processing - Working Experience
Lean Assessment - Extensive Experience
Problem Solving - Extensive Experience

Nice To Haves

Master of Science (M.S) (Preferred)
5+ Years of Experience in a Manufacturing Environment (Preferred)
Experience in Medical Device Manufacturing (Preferred)
Any Quality Certification (Preferred)
Process Management - Working Experience
Communication - Working Experience
Accuracy and Attention to Detail - Working Experience
Lean Manufacturing - Working Experience
Statistical Analysis and Measurement - Working Experience
Production Part Approval Process (PPAP) - Working Experience
Production Runs - Extensive Experience
Final Inspection - Extensive Experience
Computer Knowledge - Working Experience
Customer Communication - Working Experience
Coaching - Working Experience

Responsibilities

Provides and documents training on standard of work instructions, policies, and procedures in a timely manner to ensure team members have the required knowledge and skills prior to performing work independently.
Uses quality tools to implement improvements including: process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques
Acts as a customer liaison and processes customer quality complaints, as applicable.
Collects, Analyzes, and Presents data using statistical methodology
Assists suppliers with the interpretation of quality requirements, as applicable.
Assists the development of essential QMS deliverables/Advanced Product Quality Planning (APQP) including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification / validation
Plans and/or conducts process and equipment validations and special validations including installation qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Determines machine and/or process capability through planning and/or executing Process Capability studies
Develops inspection criteria that connect customer requirements and manufacturing processes that include identification of key characteristics, associated sampling plans, and required gauging.
Interfaces with appropriate customer contacts to clarify customer requirements
Conceives and/or Leads productivity improvements and/or Continuous improvement projects
Monitors engineering production processes and products for adherence to internal and external requirements and practices.
Participates in pre- and post-production launch reviews providing quality engineering support
Performs quality reviews and internal audits; evaluates data and writes associated reports
Recommends modifications to existing quality or production standards, where applicable, to achieve optimum quality within limits of equipment capability.
Reviews and approves product/process and document change requests.
Reviews drawings to evaluate quality requirements including: correct application of geometric dimensioning and tolerance, proper use of process and material specifications, and key characteristics for inspection plans and gauging techniques.
Supports measuring and analyzing key metrics to monitor performance.
Works with cross-functional teams to solve production and quality problems.
Creates and manages the overall course structure and sets up course programs based on specifications.
Reinforces safety expectations.
Ensures safety operating practices are demonstrated.
Reports issues/concerns to Supervisor.
Support quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS).