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- Designated member of the complaint handling unit. Performs responsibilities of a Complaint Handling Unit designee including containment, root cause analysis, corrective action, review and reporting for customer returns and complaints.
- Supports continuous improvement as a change agent for internal rework and scrap reduction and process optimization.
- Liaise with suppliers and customers to establish acceptance criteria, inspection methods, address concerns, and resolve issues.
- Assists in 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.
- 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.
- Work with Engineering to document or revise current processes and parameters and develop written instructions to eliminate unnecessary process variation.
- Performs quality reviews and internal audits; evaluates data and writes reports to validate or indicate deviations from existing standards.
- Perform necessary training related to CAPA's and continuous improvement efforts.
- Mentors quality and production personnel on problem solving and proper inspection techniques.
- Works with cross-functional teams to solve production and quality problems.
- Use handheld inspection tools for measurement purposes, such as micrometers, calipers, height gages, optical comparator, gage blocks/pins, and dial indicators.
- Perform visual and/or cosmetic inspection of product following applicable procedure(s) using appropriate light sources. Monitor equipment to ensure proper operation and escalate any equipment-related issues.
- Support the Quality Management System (QMS) by utilizing One Orchid global processes, complying with applicable 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.
- Back up the Quality Documentation Coordinator on Regulatory Release activities per FDA 21 CFR 820.80 (d) when required.
- 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 one Orchid
- Results: Our results matter
- Corrected 20/20 vision
- Constantly operates a computer
- Must be able to remain in a sitting position 50% of the time
- Must be able to remain in a standing position 50% of the time
- Occasionally visually inspect parts
- Occasionally lifts and/or moves up to 50 pounds
- Ability to work mandatory overtime and weekends as required
- Frequently grasps objects
- Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements
- Candidates must be able to provide proof of eligibility to work in the United States through eVerify