SUMMARY DESCRIPTION

Directs and participates in quality assurance efforts to ensure that the Company?s products conform to quality standards and that processes and controls adhere to regulatory requirements.

SUPERVISION RECEIVED

Under direct supervision of Director of Quality Assurance. Normally receives no instruction on routine work, general instruction on new assignments.

SUPERVISION EXERCISED

Manages the direct operation of the Calibration and Environmental Monitoring programs, through direct supervision of the Calibration Technician.

?         Works with suppliers in resolving quality issues with non-conforming raw materials and components by implementing Corrective and Preventive action.

?         Performs supplier audits and works with the Materials department in vendor qualification and development.

?         Develops and improves inspection techniques.

?         Ensures inventory accuracy of Receiving Inspection area.

?         Manages MRB process and ensures non conforming product is dispositioned in accordance with applicable regulatory requirements.

?         Establishes Root cause and appropriate Corrective/Preventive Action to eliminate existing or potential non-conformance conditions.

?         Supports Receiving Inspection work flow to maintain backlog at acceptable levels.

?         Provides necessary training for inspection and production personnel as may be required.

?         Maintains Sterile Product and Sterilization Cycle validations.

?         Responsible for the Environmental Monitoring Program of the CER.

?         Generates and maintains quality assurance standards, procedures and controls.

?         Works directly with Product Engineering to address corrective actions and out-of-control events.

?         Creates and submits Engineering Changes, Drawings, Procedures, Rework Instructions and Variance Authorizations as required.

?         Participates and supports Corporate Product Development Process as related to supplier development/qualification, quality processes/tooling, and risk management activities such as FMEA. 

?         Oversees Calibration Program through direct supervision of technician.

?         Develops and coordinates execution of process validation protocols and reports ensuring proper statistical analysis is applied.

            Develops analysis methods for determining reliability of components, equipment, and processes.  Acquires data and performs analysis of data.

?         Experience with HALT, HASS, and Compliance testing.

?         Applies statistical and QE tools such as SPC, DOE, Hypothesis testing, R&R cage studies.

?         Supports the internal audit program as required.

?         Practices and promotes Good Manufacturing Practices in accordance to the QSR and MDD.

?         Perform the role of Reviewer in the Complaint Management and CAPA systems.

We are committed to creating an environment where all employees are valued and respected.  We offer a competitive benefits package including 401(K) savings plan with match, medical, vision, dental, life insurance, tuition reimbursement, and employee stock purchase plan.

To find out more about our company, visit our website at: http://www.integra-ls.com/home/careers /

No Agencies.  LOCAL CANDIDATES ONLY PLEASE.  EOE, M/F, D/V

Integra is not currently accepting unsolicited assistance or resumes from search firms for this employment opportunity.  All resumes submitted by search firms or agencies to  Integra or its employees, agents, directors or representatives in any form or method without a valid written agreement covering this  position will be deemed the sole property of Integra.  No fee shall be paid in the event the candidate is hired by Integra as a result of the referral or through other means.

Search firms are essential to the recruitment and staffing efforts at Integra and we value the partnerships we have built with our preferred vendors. For this reason, Integra has established and regularly maintains a vendor list. Please note that even preferred vendors are required to have a written search agreement signed by an authorized signatory of Integra in order for a fee to be paid for any candidate referrals.