Senior Quality Assurance Engineer - Tissue Regeneration Products Medical Device

Job description (Tasks/Responsibilities):

The Senior Quality Assurance Engineer will participate in cross functional teams to ensure the effective implementation of design controls in support of the development and launch of Allograft, Xenograft, and AB coated tissue regeneration products.  Successful candidates will have proven leadership skills and demonstrated ability in risk based decision making and problem solving.  This position reports to the Senior Advanced Quality Engineer and is responsible for assuring that new product designs and processes meet all corporate and divisional requirements with respect to safety and efficacy. Your responsibilities include: Support design control activities for new product development process and regulatory submissions. Provide technical guidance to Quality Engineers, Quality Technicians, and Inspectors. Lead Quality Engineering Projects to improve systems and procedures. Perform product and process risk assessment activities, including Hazards Analysis, and Lead Design/Process Failure Modes & Effects Analysis (DFMEA/PFMEA). Conduct and lead design verification/validation and process validation activities. Provide Quality Engineering leadership for analytical test methods and stability testing in order to ensure compliance with ICH guidelines, ISO-13485, 21CFR 820, 210, 211, 1270, 1271 and/or requirements as applicable. Develop biocompatibility test plans in compliance with ISO-10993 and Corporate guidelines.  Co-ordinate the testing at outside laboratories and document results. Develop, document, and validate Inspection and Test Methods to support design control, in-process inspection, and final inspection activities. Develop shelf life and stability test protocols for combination devices with Active Pharmaceutical Ingredients (API’s). Develop manufacturing control plans for internal and outsourced processes. Support Corrective and Preventive Action Process for product/process non-conformances, customer complaints, and internal audits. Support Product/Process Transfers from Pilot facilities to Manufacturing Facilities. Perform additional duties as assigned.

Skill Requirements:

Bachelor’s Degree required in Engineering or other technical discipline. Minimum of five years of experience in a quality, manufacturing, or R&D engineering, including design controls or product/process validation and technical problem solving, in the medical products industry. A high level of competence in quality technology including statistical techniques, control charts, sampling plans, quality costs, design of experiments, correlation and regression, analysis of variance, probability etc. Knowledge of FDA QSR’s, cGMP’s and/or cGTP’s, and ISO regulations. Knowledge of Xenograft, Allograft, and/or combination products utilizing absorbable polymers and active pharmaceutical ingredients is a plus. Knowledge and Application of Six Sigma/Process Excellence Tools.  Green Belt/Black Belt Certification a plus. Occasional travel - 10%.

Education Requirements:

Bachelor’s Degree required in Engineering or other technical discipline.

Location (City/State):

Warwick, RI

Company Description:

A market leader in comprehensive soft tissue reconstruction, delivering trusted products and techniques for hernia repair, specialized surgical procedures, fixation and biologic implants.

To Apply:

To apply, contact Tracy Wolfe at twolfe@zingaro.com or (512) 327-7277