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Quality Engineer
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Packaging validations, product shelf life studies, sterilization validations and dose audits in co-operation with external contract manufacturers.
- Prepare and conduct monthly quality meetings and keep management informed of quality issues.
- Support material review board (MRB) with investigation and disposition of nonconforming materials.
- Implement and verify effectiveness of corrective and preventive actions (CAPA).
- Collect and perform analysis of data such as manufacturing, shipping, sterilization data in support of quality objectives.
- Perform internal audits and/or supplier audits as needed.
- Maintain understanding of regulatory requirements, guidance documents and applicable testing standards.
- Represent the company during customer visits, audits, and inspections.
- May act as a liaison with regulatory agencies (FDA, ISO, other) during quality system inspections and/or audits.
QUALIFICATIONS INCLUDE:
- Bachelors in Mechanical Engineering
- 2+ years of Quality experience in Medical Devices or biologics, with experience in quality control and quality assurance systems. Experience working with manufacturing operations is preferred.
- Experience with quality system regulations: cGMP, 21 CFR 820, QSR, ISO 13485, CMDR, MDD.
- Experience with validation (IQ, OQ, PQ).
- Creative problem-solving skills
- Proficient with Microsoft Word, Excel, PowerPoint and statistical analysis software.
- Leadership and independent judgement experience.
- Ability to work independently.
- Authorization to work in US indefinitely without restriction or sponsorship.
Prosidyan, Inc. is an Equal Opportunity Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.