Director of Quality Assurance

Job Description

AgaMatrix invents, manufactures, and markets blood glucose monitoring (BGM) and diabetes management products. Based on its proprietary WaveSense dynamic electrochemistry technology, their meters are more accurate and they can improve manufacturing yields, a key industry challenge. AgaMatrix has shipped >1 million meters and almost 1 billion biosensors (strips) across several FDA-cleared product lines in this $9 billion market.

The company has >100 patents and is known for its user-centric product design. We are driven, passionate people who value innovation and perseverance, while still enjoying a collegial, familial atmosphere where colleagues are helpful both in and out of the office. Our people come from a variety of backgrounds from biochemistry and algorithm design to industrial design and regulatory affairs, so you will have the chance to learn from many different disciplines.

Recently, sanofi-aventis, the world's 4th largest pharmaceutical company, entered into a long-term relationship with AgaMatrix to market and sell a series of diabetes management products manufactured exclusively for them, selecting the company based on their accuracy and innovativeness. In recent years, AgaMatrix has broken ground in the connected health space with several hardware, software, and web services offerings, including the world's first and best-rated diabetes iPhone App by a BGM maker, and the world's first BGM-to-iPhone download system. The company is based in Salem, NH, half an hour north of Boston.

WE ARE GROWING! This new position is a tremendous opportunity to have a high visibility role within our organization. If you are ready to take the next step in your career, we would like to talk with you.

The Director of Quality Assurance will develop, implement and coordinate product assurance programs to prevent or eliminate defects in new or existing products.
This position will have overall responsibility for assuring that AgaMatrix Quality system requirements are effectively established, implemented and maintained in compliance with CGMP's and other regulatory requirements . In this role you will -

* Be in charge of internal quality audits, as required, to assure that the Quality System is in compliance with the established Quality System requirements and to determine its effectiveness.
* Facilitate all external customer matters relating to AgaMatrix quality system.
* Chair Quality System Management meetings which gather and report on the on AgaMatrix Product Quality and related System.
* Lead initiatives to establish, and review assurance program, maintain product quality to coordinate functions and operations between departments establishing responsibilities and procedures for attaining objectives.
* Analyze, evaluate and present information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends and design and development of new products for consideration by other members of the management team.
* Participate in the correction, prevention and documenting customer complaints investigations which may be relating to possible medical device reporting as required by Regulatory Affairs.
* Responsible for approving shipment of product meeting quality standards; stops shipment of product that does not meet quality or regulatory requirements ; escalates product quality issues to the Corrective Action process for resolution if necessary.
* Assure that all sites globally are trained and understand all current Quality System requirements.
* Review technical problems and procedures and recommends solutions to problems or changes in procedures.
* Confer with engineers about quality assurance of new products designed and manufactured products on market to rectify problems.

COMPENSATION and CONTACT
AgaMatrix is pleased to reward our associates with competitive compensation packages that include paid time off, health, dental, and life insurance, LTD, and 401k with company match.

Start your journey at AgaMatrix by forwarding your resume to hr@agamatrix.com with "response to job posting" along with appropriate "job title" in the subject field. Telling us why you would be a good match for AgaMatrix along with your salary requirements will speed the process.

Agamatrix is proud to be an Equal Opportunity Employer.

Job Requirements

Preferred candidates will have a Masters in Engineering or a related discipline and 10 years relevant experience; or equivalent combination of education and experience.
* Must have hands on experience with ISO9001 and ISO 13485
* Must be a results driven individual that continuously challenges the function and organization for continuous improvement and delivers the results in Quality, Compliance and Productivity

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