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Sr Quality Engineer Jobs
Company | SeaSpine |
Address | Irvine, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Medical Equipment Manufacturing |
Expires | 2023-09-14 |
Posted at | 9 months ago |
We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginning!
- Support for design controls
- Lead small project teams as needed to accomplish project objectives.
- Support the Quality Management System (e.g., facilitate change orders, CAPAs, Document Control, and Design Control System).
- Participate in New Product Initiatives to ensure smooth transitions to production.
- Use quality engineering tools to for problem solving (e.g. FMEA, SPC, DOE).
- Analyzes complex production and quality trend data to identify and solve problems.
- Manage and conduct both internal and external audits and qualify new suppliers and/or components.
- Provide QA investigational support for product NCRs, CAPAs and Complaints
- Provide QA technical support in order to ensure compliance with FDA, ISO, EN, AATB, and other national and international standards, to assure product quality and safety.
- Implement changes to products and manufacturing to improve quality and reliability and to address improvement of process, design, or materials.
- Conduct risk management/risk assessment activities.
- Support Risk Management activities for the HHE, Complaint and CAPA process.
- Support post market activities such as complaint investigations, complaint trending, CAPA and FCA.
- Preside as a key quality participant in compliance audits and FDA inquiries.
- Perform equipment, product, and process qualifications/validations.
- Interface with Suppliers to review specifications, address supplier corrective actions and resolution of quality programs.
- Works with the Calibration department on development of gauging, review and approve calibrations to requirements and conduct Out of Tolerance investigations.
- Bachelor’s Degree in Engineering or Biological science
- Must have the ability to multi-task in fast paced environment
- Mastered regulatory compliance awareness, including at a minimum 21 CFR 820, 21 CFR Part 11, ISO 13485, ISO 14971, MDD. Knowledge of 21 CFR 1271 preferred
- Minimum 5 years of related experience with exposure to medical device products
- ASQ C.Q.E. and/or C.Q.A., Lean, Six Sigma, Process Excellence - preferred
- Demonstrate experience and understanding in use of statistical tools
- Must have technical and organizational skills
- Must have strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of moderate scope and complexity
- A combination of advanced degree & related work experience may be considered
- Excellent communication skills, both verbally and in writing
- Ability to interact with all levels of personnel throughout the organization
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