As our QA Manager you will be responsible for and oversee our QA area, focusing in the following areas: engineering, product development, manufacturing, validation and qualification. As an independent contributor you will ensure customer and regulatory requirements have been met by inspecting product and reviewing documentation throughout all aspects of the production process. You will develop standard methods for inspection, testing, validation strategies and tools utilizing knowledge in related engineering fields. You will work closely with other departments to support the supplier management program, qualify and routinely monitor supplier performance and maintain calibration requirements and implementation of systems.


Principal Duties and Responsibilities:

  • Perform and document incoming activities, in-process control, final quality control, and non-conformance related activities and provide periodic reporting of status
  • Responsible for database management for inspection records and for release of finished goods
  • Manage the schedule and logistics of all equipment calibration and labeling
  • Communicate and coordinate with other quality, engineering and manufacturing personnel on the inspection criteria, tools, and inspection results
  • Maintain the flow of electronic controlled documents, department files and resource materials
  • Complete quality assurance projects in a manner consistent with corporate objectives
  • Support company goals and objectives, policies and procedures, good manufacturing practices, and FDA regulations

 

Required Qualifications

  • BS in engineering (biomedical, mechanical, industrial, operations, or quality)
  • 5+ years of industrial experience
  • 3+ years of quality systems experience in the medical device industry
  • Experience with design control, change control, design verification and product validation, non-conforming material, auditing, CAPA and records maintenance
  • Hands on experience in developing testing protocols and manufacturing processing control
  • Strong working knowledge and experience in optical and electro-mechanical inspection methods and using inspection tools
  • Experience with automated test environment and testing techniques with emphasis on test architecture, tools, and change management
  • Experience with US and international medical device regulations, especially FDA 21 CFR 820, ISO 13485, IEC 62304, IEC 61010, IEC 60601 and ISO9001
  • General computer skills and experience using Microsoft Access, Word, Excel, and PowerPoint
  • Ability to work independently and collaboratively
  • Must be able to follow established policies and procedures, recommend changes in existing procedures, and comply with regulatory requirements
  • Ability to communicate at a high level with peers, leaders and vendors/clients
  • Excellent written and verbal communication skills

 

Company Description

At Aquyre Biosciences Inc. (Cambridge, MA) our mission is to become the standard of care for tissue adequacy assessment. Tissue and biopsy assessment is critical for the proceduralists doing the biopsies, for the patients who need immediate information and Next Generation Sequencing that requires enough live cancer cells.At Aquyre Biosciences Inc. (Cambridge, MA) our mission is to become the standard of care for tissue adequacy assessment. Tissue and biopsy assessment is critical for the proceduralists doing the biopsies, for the patients who need immediate information and Next Generation Sequencing that requires enough live cancer cells.

 

What makes Aquyre Biosciences Different? We combine two unique and proprietary technologies in one exam, offering a non-invasive, non-destructive, intra-procedural tissue adequacy assessment, in freshly excised tissue, within 2 minutes. Our technologies capture unique data on architecture at high resolution (1 µm in 3D) and microscopic intracellular activity and behaviors in freshly excised tissue, without staining or destroying the tissue.

 

Aquyre Biosciences Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment regardless of race, color, religion, sex, sexual orientation, disability status, or any other characteristic protected by law.

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