QUALITY ENGINEER: Job Code D-01
MISSION STATEMENT: Introduce robust quality programs and practices to evaluate processes and identify areas that lead to efficiency or quality issues, evaluate cause of problems and analyze quality data, implement root cause corrective actions, and evaluate results. Designs, evaluates and implements quality assurance programs and systems for manufacturing and development to ensure compliance with regulatory requirements. Develops methods, protocols and assays to ensure that appropriate quality tests and analyses are being conducted. Works with quality and manufacturing to create and /or modify methods and procedures to ensure those appropriate tests are conducted and that products, materials and manufacturing equipment meet required standards.
SPECIFIC RESPONSIBILITIES: 1. Investigate and perform root cause analyses of process deviations and out of specification results. Prepare detailed reports summarizing investigation results and outlining recommended corrective actions. 2. Coordinate the implementation of corrective actions and routine change controls. Work closely with manufacturing, QA, QC, engineering and facilities implement changes. Regularly report status to Director of Quality and provide summaries of open items. 3. Design and maintain procedures and systems for process and quality data collection. Perform statistical analysis to analyze trends and improve process control. 4. Develop and perform process capability evaluations and determine critical process control points and appropriate control limits. 5. Work with quality and manufacturing to create/modify methods and procedures to ensure appropriate tests are conducted and that products, materials and manufacturing equipment meet required standards. 6. Implement systems to measure and track supplier quality. Develop metrics, track performance and report on results. 7. Oversee implementation of the calibration program. Ensure timely calibration of instrumentation and investigation of out of tolerance results. 8. Perform GAP analyses of in-house practices versus relevant regulations, standards and industry practices. Develop plans and implement corrective actions to ensure continued compliance. 9. Design and conduct periodic audits of quality system processes and procedures to ensure compliance.
EXPERIENCE: • Requires a Bachelors/Master Degree in engineering or related discipline with a minimum of 2 to 5 years related experience and demonstrated working knowledge of scientific principles. • Strong knowledge of statistical process control methods and techniques • Familiarity with regulated industries, FDA, ISO etc. • Working knowledge of cGMPs, QSRs, MDDs. • Familiarity with the principles of Design Control. • Working knowledge of Six Sigma a plus. • Strong writing and presentation skills

SR. QUALITY ASSURANCE SPECIALIST:
Job Code D-02
The qualified candidate will assist in the routine performance of Quality Systems to assure compliance with in-house specifications, standards and cGxPs, with an emphasis on auditing, documentation, data review and training. Responsibilities include the production of batch record/test report review, SOP review and approval, review and maintenance of investigations and change control requests. This position will require 5-10% travel both internationally and within the US. The successful candidate will have a BS or equivalent and 5+ years of relevant QA or industry experience. Demonstrated knowledge of GMP operations will be required. Experience in both internal and external compliance audits is required. Strong written and verbal communication skills, as well as strong organizational skills are required in order to assure that turnaround times are met in support of further manufacturing. Knowledge of GLP is desired and GCP is preferred.

PROCESS DEVELOPMENT ENGINEER: Job Code D-03
MISSION STATEMENT: Responsible for the development of new products, processes and technologies based on core technologies to meet market needs and corporate objectives. Generates new concepts/technology in the area of tissue protection, regeneration and healing.
SPECIFIC RESPONSIBILITIES: 1. Work with research and business development to identify market needs and evaluate technologies to design and develop cost effective products. Develop appropriate design inputs defining product performance requirements. 2. Use experiments, literature searches, internal and external interactions to develop formulations, characteristics and delivery systems that address product performance requirements. 3.Lead the product design efforts for new product concepts. Direct internal resources and coordinate external collaborations to design and test product concepts. 4. Design processes to cost effectively produce product meeting critical product attributes. Perform experiments to screen critical process control factors. Use experimental design techniques to develop robust processes at the laboratory scale. 5. Develop detailed procedures for the new processes and work prepare appropriate specifications for materials, components and product testing. 6. Design, specify and test equipment required to manufacture products. 7. Lead or participate in diverse project teams in the development, optimization, transfer and validation of processes to pilot scale. 8. Maintains detailed documentation throughout all phases of research and development. Prepare comprehensive development reports detailing procedures, test methods, results and conclusions of all work. 9. Maintain current, up-to-date, design control documentation meeting requirements and industry standards. 10. Participate in the development of patent applications.
EXPERIENCE: • BS/MS in chemical engineering, or related discipline, with 3 to 7 years experience. Specific experience in general areas of tissue engineering, biomaterials or drug delivery is a plus. • Experienced in early stage product development. Understands the scientific, regulatory and clinical hurdles to commercialize product concepts. • Well-organized individual with ability to handle multiple projects efficiently. Possesses high energy. Has excellent interpersonal skills. • Experience in experimental design required.