Orchid Orthopedic Solutions Senior Quality Engineer, Orchid Oregon in Oregon City, Oregon
SUMMARY OF POSITIONThe Senior Quality Engineer, Quality supports the establishment and maintenance of quality system processes for Orchid Oregon. This position will act as an ISO 13485:2016 and 21 CFR 820 quality system subject matter expert (SME). The Senior Quality Engineer will support on site customer, regulatory agency and notified body audits. In addition, this position will provide input to colleagues within all areas of the quality management system (QMS) including, but not limited to the following areas CAPAs, NCMRs, Feedback and Complaints, Supplier Quality and Internal Audits.
This position reports directly to the site quality leader.
WHAT YOU WILL DO
- Uses quality tools to identify significant trends and implement improvements including: process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility.
- Monitors engineering processes and products for adherence to company and regulatory standards and practices. Leads and participates in quality improvement initiatives and projects related to systems, processes and products.
- Leads reviews of key quality system processes by; evaluating data and writes reports to validate or indicate deviations from existing standards.
- Acts as coordinator for site internal and supplier quality audit programs; develops internal and supplier audit schedules, plans and conducts audits. Provides guidance for certified internal auditors during audits where a team is required.
- Drafts and aids in execution of process and equipment validations.
- Acts as a customer liaison and supports processes customer quality complaints.
- Assists the development of essential QMS deliverables including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification/validation.
- Reviews and approves change requests.
- Work with production to document current process parameters and develop written instructions to eliminate unnecessary process variations.
- Participates in pre- and post-production reviews providing quality engineering support.
- Collects the required data and chart the quality goals established by the management team.
- Supports measuring and analyzing key metrics to monitor performance.
- Leads productivity improvements by providing quality guidance.
- Works with cross-functional teams to solve production and quality problems.
- Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.
- Lead quality and compliance by utilizing One Orchid global processes and complying with all Quality Management Systems (QMS) documentation requirements and establishing/supporting plan(s) to meet/exceed Key Performance Indicators (KPIs) for Quality that support Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD) and financial objectives.
WHAT WE ARE LOOKING FOR
5+ Years of Experience (Required), 5+ Years of Experience in a Manufacturing Environment, Experience in Medical Device Manufacturing
Bachelor of Science (B.S): Engineering (Required), Master of Science (M.S): Engineering
Quality Certification - CQE
KNOWLEDGE & SKILLS THAT ENABLE SUCCESS
Collaboration (Working Experience), Final Inspection (Extensive Experience), Manufacturing Regulatory Environment (Extensive Experience), Problem Solving (Extensive Experience), Production Part Approval Process (PPAP) (Extensive Experience), Production Runs (Extensive Experience), Statistical Analysis and Measurement (Extensive Experience)
WHAT WE OFFER
- Opportunity to work in a growing company
- Ability to help people live a longer, more active life
- Comprehensive benefit package
- Ability to work in an organization that values:
- Integrity First: We do the right thing
- Teamwork: We are all connected
- Results: We are all driven
- Not Applicable
- Candidates offered employment must submit to a pre-employment background check and pre-employment drug test
- Candidates must be able to provide proof of eligibility to work in the United States through eVerify
EOE, including disability/vets
Position: Senior Quality Engineer, Orchid Oregon
Company: Orchid Orthopedic Solutions
Job Location(s): Oregon City, OR
Start Date: As soon as possible
Employment Term: Regular
Employment Type: Full Time
Starting Salary Range: Not Provided
Required Education: Bachelor's Degree
Required Experience: Open
Required Security Clearance: None
Related Categories: Engineering - General, Quality Assurance/Safety, Engineering - Electrical