Job description
Putting a new spin on your career
Working at CSI means being a part of something greater than ourselves. We think big and move fast. From creating revolutionary technologies, to working with world class physicians and teams, we don’t simply work, we save lives. We have big company drive and small company vibe where your daily impact can be felt company-wide. If you are curious, ambitious and dedicated, you will love our community. Grow with us!
Job Description:
Job Summary:
Responsible for ensuring the quality of products by providing quality engineering support to manufacturing. Investigates and dispositions nonconforming material and participates in CAPA and continuous improvement initiatives. Authors and updates documentation within the quality system with robust justification. Maintains routine microbial control process and trending.
Essential Duties and Responsibilities:
- Assures compliance to external, FDA, ISO, MDD, and internal quality policies and procedures for manufacturing and product development.
- Material Review and Nonconforming Material. Manage and facilitate Non-conforming Material Report (NCMR) process.
- Corrective & Preventive Actions. Conduct product investigations, root cause analysis, and implementation of corrections and preventive actions. Organize efforts to resolve production issues and assist with supplier issues to reduce production and incoming inspection NCMRs.
- Oversee and review routine microbial controls, such as bioburden, endotoxin, and environmental monitoring.
- Coordinate sterilization revalidations and monitor vendor sterilization programs for compliance to applicable standards.
- Review and approve process, equipment, and test method validation plans/protocol and reports that are comprehensive, clearly written and technically sound for execution.
- Collaborate with Operations and Manufacturing Engineering to drive continuous improvement initiatives.
- Conducts evaluations, tests, verifications, and validations to maintain Quality objectives.
- Applies policies and procedures for identifying, analyzing and controlling risk throughout the product life cycle.
- Work as an integral member of the Quality Engineering team to complete key activities and projects.
Qualifications:
- Bachelor’s degree in an Engineering discipline
- Minimum of 2 years’ experience in quality assurance in the medical device industry.
- Working knowledge of and experience planning and performing quality engineering duties in compliance with medical device regulations and standards including 21 CFR 820, ISO 13485, ISO 14971, and MDD/MDR.
- Strong background in application of statistical methods and quality engineering techniques and tools (i.e., Gage R&R, DOE, AQL). Mini-Tab experience preferred.
- Excellent organizational ability, capability to manage multiple, dynamic projects simultaneously.
- Ability to read drawings and understand tolerancing.
- Understanding of mechanical design concepts and risk analysis techniques; FMEA, Fault tree, Hazard Analysis.
- Familiarity with machined components and plastic injection molded components.
- Experience with supporting internal and external audits.
- Experience in CAPA and nonconforming material investigation and reporting.
- Recognize problems and take corrective measures.
Specifications/Other
- Must be able to lift 25 lbs
- Work is performed on-site in an office environment with exposure to electrical office equipment.
- Must be able to look at a computer screen for up to 8 hours per day
CSI is an EEO/AA company: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. If you are a job seeker with a disability and require accessibility assistance or reasonable accommodation to apply for an open position, please contact the Recruiting Department at Cardiovascular Systems, Inc., 1225 Old Hwy 8, New Brighton MN 55112, or call (651) 259-1600
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