As a key member of the Quality team, the Senior Lab Technician will be responsible for the biological safety testing of receiving inspection lots, devices and materials for regulatory submissions, and for management of the lab space, equipment, and supplies. You will also be planning and conducting activities concerned with the quality assurance of processes, materials, and products and assisting in the management of selected Quality Systems. This position will work to maintain elements of Quality Management Systems (QMS) in accordance with ISO 13485 and FDA 21 CFR 820 requirements as well as company protocols. This is an on-site position.
Responsibilities as it related to the QC Lab
- Perform testing and review results.
- Demonstrate laboratory troubleshooting skills and critical thinking.
- Equipment maintenance & daily QC.
- Prepares test orders and specimens for testing and/or transfer to reference laboratory.
- Performs inspections/testing and quality release (raw materials, in-process, and product release) in a clean room environment.
- Assist in writing or reviewing newly written or revised validation plans, test methods, and/or procedures as applicable to the lab and review the completed validations for accuracy and completeness.
- Maintain laboratory areas and equipment in a safe, functional and sanitary condition.
- Report any actual or potential deviation from standard or accepted testing procedures and cooperate fully with any investigation of same.
- Supports audits as required.
Responsibilities as it relates to Manufacturing
- Serves as a quality technician by performing inspections/testing and quality release (raw materials, in-process, and product release) in a clean room environment.
- Assist in maintaining and/or developing companywide Quality systems including, but not limited to, quality audits, product validation, acceptance activities, production and process control, and corrective and preventive action.
- Documents data obtained during all quality assurance activities, consistent with company policies and procedures.
- Ensures that the implemented changes and corrective action to rectify non-conformance issues are respected in the manufacturing line.
- Supports continuous improvement initiatives to enhance quality processes.
- Responsibilities relate to Complaint Handling
- Complaint handling and reporting with customers based on business needs at the discretion of the Quality Engineering Manager
Qualifications:
- Associates Degree or Bachelor’s degree
- 3-5 years of experience in medical devices and manufacturing
- Exposure to ISO and FDA regulations
- Self-directed with excellent attention to detail.
- A strong knowledge of basic mathematical operations is desirable.
- Demonstrated verbal and written communication skills.
- Demonstrated computer skills and a working knowledge of computer software (MS Outlook, MS Word, and Excel).
- Must have the ability to work in a fast-paced environment with an attention to detail, organization, and time management skills are required.
- Versatile, with a demonstrated success working independently and in a team environment.
Salary :
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