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Product Evaluations Technician I
2 months ago
The Product Evaluations Technician I has the overall responsibility for execution of studies, for the reporting of study results, and to maintain / ensure compliance with applicable standards and company quality systems.
Biomedical Device Consultants and Laboratories (www.bdclabs.com) is a fast-growing company that offers comprehensive medical device testing services, design verification test equipment, and silicone mock vessels to the medical device community in support of domestic and international regulatory submissions and approvals. Our primary focus is cardiovascular technologies such as endovascular stents, prosthetic heart valves, and surgical catheters. As a small company, BDC's environment is fast-paced, dynamic, challenging, and rewarding. Our company's products and our mission enrich and saves lives.
Role Responsibilities:
- Ensuring equipment is adequately calibrated, inspected, cleaned, and maintained prior to use in a study.
- Ensuring all reagents and solutions in the laboratory areas are labeled to indicate identity, titer or concentration, storage requirements, and expiration date.
- Ensuring functions performed are clearly understood and conducted in accordance with the approved protocol.
- Ensuring all data generated during the conduct of a laboratory study, except those that are generated by automated data collection systems, are recorded directly, promptly, and legibly in ink and data documentation procedures followed.
- Ensuring all experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.
- Ensuring all raw data, documentation, protocols, final reports, and specimens (as appropriate) generated as a result of a laboratory study are retained.
- Performing data analysis and created software scripts and templates to perform data analysis.
- Ensuring unforeseen circumstances that may affect the quality and integrity of the laboratory study are noted when they occur, escalated to appropriate personnel and corrective action is taken and documented.
- Participating in regulatory inspection activities with regulatory agencies, as needed.
- Participating in the Quality Management System including, Document Control, Employee Training, Purchasing, Work Order Program, Corrective and Preventive Actions, Controlled Equipment management, Internal Audits and Record and Data Control.
Minimum Qualifications of Position:
- High school diploma or general education degree (GED); and minimum of 2 years of technical experience.
- Understanding of quality system requirements including ISO/IEC 17025 and 21 CFR part 58 is required. Experience in 21 CFR Part 820 and Part 11, ISO 13485, and other relevant international standards is highly desirable.
- Must be organized, with analytical and problem-solving abilities.
- Ability to read and interpret technical procedures and governmental regulations; along with the ability to effectively present information and respond to questions from managers and team members.
- Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
- Strong verbal and writing skills and good interpersonal skills.
- Proficiency with a Windows environment, (Word and Excel) required.
BDC Laboratories is an Equal Opportunity Employer
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