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Quality Analyst Jobs
Company | STERIS |
Address | Spartanburg, SC, United States |
Employment type | FULL_TIME |
Salary | |
Category | Medical Equipment Manufacturing,Hospitals and Health Care |
Expires | 2023-08-19 |
Posted at | 10 months ago |
At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
- Perform internal audits at other AST facilities, including identification of non-compliances and report generation. Responsible for managing remediation of internal audit observations assigned by site Quality Manager.
- Responsible for executing product and/or report releases for all processing runs/lab samples containing a non-conformance, including management of Customer communication and leading the associated non-conformance investigations.
- Perform other duties as assigned.
- Initiate and/or participate in corrective actions, problem-solving and continuous improvement activities.
- Review collected data to perform statistical analysis and recommend process changes to improve quality.
- Manage creation of new quality system policies and procedures and revisions to existing policies/procedures.
- Monitor and report on performance metrics.
- Overall responsibilities include commitment to ensure external and internal requirements ar met according to documented policies, procedures, standards and regulations.
- Responsible for oversight of all product and/or report pre-reviews and releases conducted by Quality Technicians/Senior Quality Technicians.
- Coordinate day-to-day tasks and direction for Quality Technicians/Senior Quality Technicians by providing technical support, mentoring and oversight.
- Collaborate with other departments and facilities within the company on quality related issues.
- Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
- Bachelor’s Degree in a related scientific/technical field required.
- 5 Years’ experience in manufacturing or processing environment or other technical/scientific field.
- 1-5 years of experience with medical device or other regulated industries preferred.
- 1-5 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
- Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.
- 1-5 years of experience working in an ISO certified environment required.
- Focus on identification of potential issues and continuous improvement.
- Demonstrated excellent organizational, oral and written communications skills.
- Ability to work in a fast-paced, regulated environment with strict deadlines.
- Mathematical skills including practical application of fractions, percentages, ratios, proportions and algebra.
- Excellent problem-solving skills
- Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
- Experience working on cross-functional teams and on own initiative.
- 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.
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