Quality Assurance Specialist

Quality Assurance Specialist

 

Established in 1989, ETEX Corporation is headquartered in Cambridge, Massachusetts. With its roots in biomaterials research, ETEX’s core expertise is developing and manufacturing calcium phosphate based materials for osteobiologic applications.

α-BSM® Bone Substitute Material is the first product to be commercialized from ETEX's technology platform. α-BSM is distributed in the United States, Canada and Australia for the treatment of bone voids resulting from fractures and other medical conditions.

ETEX has assembled a talented group of scientists and chemical engineers who possess an in-depth understanding of calcium phosphate chemistry and synthesis, including adaptations which correlate to variable material properties. Our team consults regularly with leading biomaterials scientists, cell biologists and clinical researchers within the global community to develop innovative products that meet the clinicians' needs

 

We are currently looking to add to staff a Quality Assurance Specialist

 

Some responsibilities of this position will include:

· overall management of Document Control (DC) functions, and

·  the administration of Record Management, and Quality Audit. 

 

 

The position also has primary responsibility for the knowledge and communication of Document Change Order (DCO) status, and administration of the Bill of Material (BOMs) system.  This individual shares responsibilities for the maintenance of the quality management system; maintenance of product quality plans, coordination of existing product risk management activities; oversight for use of sampling plans; identification, implementation, and review of process monitoring and controls; as well as participation in process optimization activities. In addition, the person in this position takes a leadership role with problem solving and special projects related to product quality, as well as for making quality system improvements.   

 

 

Qualifications:

 

1) Bachelor of Science Degree preferred.

 

2) At least one year experience in a Quality Assurance role.  Experience in, and knowledge of Federal Regulations (QSR), or International standards (ISO) preferred.

 

3) Strong interpersonal skills.  Ability to work effectively with and gain cooperation from others.

 

4) Excellent written and verbal communication skills.  Ability to edit or write Quality System procedures following established document formatting guidelines.

 

5) Works on problems with a moderate scope, exercising judgment within defined procedures and practices to determine appropriate actions.

 

6) Well organized, and can handle multiple, concurrent projects.

 

7) Demonstrated proficiency using computers with standard office applications.

 

Essential Functions:  The individual in this position may be required to perform all or a combination of the following Essential Functions as determined by the business needs:

 

1) Review and edit formal changes to Quality System documents for compliance to Document Change Order procedure.  Ensure that Document Control-related policies and practices are compliant with applicable regulations, and standards (e.g. QSR, and ISO).  Identify and help to resolve issues related to non-compliance.

 

2) Oversee documentation change (DCO) system, including: a) document change review and approval, b) document issuance and retrieval, and c) document archival functions. 

 

3) Administer Quality Record Management function, including: a) identification, classification, and archival of records, b) updating archive indices, and c) management of off-site storage contractor(s).

 

4) Administer Quality Auditing function, with support from Manager of Quality, including: a) publishing audit schedules, b) publishing periodic status reports, c) management of audit records, and d) following up on timely submission of audit reports, and associated CAPAs generated from internal audits.

 

5) Participate in Internal Auditing and Supplier Audit functions.

 

6) Administer Bill of Material (BOM) system, including creating and/or revising BOM’s.

 

7) Ensure that Document Control-related policies and practices are compliant with applicable regulations, and standards (e.g. QSR, and ISO).  Identify and help to resolve issues related to non-compliance.

 

8) Participate in continuous improvement efforts to ensure that the Quality Assurance functions contribute to ETEX efficiency and quality goals/expectations.

 

9) Participate in maintenance of product quality plans, coordination of existing product risk management activities; oversight for use of sampling plans; identification, implementation, and review of process monitoring and controls; as well as participation in process optimization activities. 

 

10) Participate in continuous improvement efforts to ensure that manufacturing processes are functioning within established standards, and/or quality goals.

 

11) Participate in efforts to ensure that policies and practices associated with quality systems are compliant with applicable regulations, and standards (e.g. QSR, and ISO).  Identify and resolve issues related to non-compliance.

 

12) Initiate, facilitate, and/or review formal changes to QC Procedures and Quality System documents, as applicable.  Provide feedback to the change originator.

 

13) Participate in efforts to resolve issues related to product quality or inspection and test methods. Assist with the review and disposition of nonconforming material.

 

If you meet with the above mentioned job requirements please forward a word copy of your resume to Jbulian@insightperformance.com .  Reference job code :Specialist