Quality Assurance Manager
PURPOSE OF THE JOB
The Quality Assurance Manager will be responsible for assessing, improving and maintaining Modulus' Quality System, policies and procedures to ensure all processes, components, subassemblies and finished products are manufactured in compliance with 21 CFR Part 820 and ISO 13485 requirements.
MAJOR DUTIES AND RESPONSIBILITIES
- Manage the improvement and maintenance of Modulus Quality System in full compliance with ISO 13485 and FDA QSR.
- Support Quality Assurance activities, including but not limited to internal and external audits, complaint handling, supplier management evaluation, NCMRs, CAPAs, management reviews, product release and document control activities.
- Perform trending analysis (Quality Metrics) on a routine basis.
- Manage the complaint handling process in collaboration with other affected departments to ensure that complaints are documented, investigated and closed in a timely manner.
- Ensure systemic product quality issues are identified and pursued through the CAPA program.
- Manage the Non-conforming Materials Review (NCMR)/ Deviations program in collaboration with Operations to ensure timely reporting, analysis, and resolution of non-conforming material/ product incidences. Address systemic quality issues with suppliers or internal groups.
- Perform/manage Incoming Quality Control activities to ensure timely inspection, including First Article Inspections, review and release of materials.
- Perform/manage review of lot history records and disposition of product (subassembly and finished goods).
- Create, review and approve Quality System Documents
- Oversees Quality Inspector(s) within Modulus.
- Provide management support to insure proper IQC, in-process and finished product test procedures are in-place, and materials and material and products are evaluated and released in an efficient and through manner.
- Interface and support audits by external regulatory bodies and any necessary follow up activities to support continued QMS compliance.
- Other duties/ activities may be necessary to support departmental or company goals.
EDUCATION AND/OR JOB EXPERIENCE
- 7-10 years quality assurance/engineering experience in the Medical Device industry. Minimum of five years managerial experience required.
- BS in life sciences, Engineering or equivalent.
- Knowledge of FDA and ISO regulatory requirements and guidelines related to medical devices.
- Experience performing lot disposition activities, managing quality processes and issues, and performing systems related audits is essential.
SKILLS AND SPECIFICATIONS
- Ability to motivate and influence people.
- Organizing, planning, and problem-solving skills.
- Good interpersonal and communication skills.
- Ability to work as a part of a team.
- Good statistical and numerical ability.
The InCube Group of Companies, San Jose, CA and San Antonio, TX
InCube Labs is a privately held, research-based organization with facilities in San Jose, CA and San Antonio, TX. At InCube, (http://www.incubelabs.com) the research is driven entirely by clinical need. As a result, we are generally agnostic to specific technologies, and tend to apply the most appropriate technology for the clinical need at hand. InCube has addressed a number of clinical needs with novel implantable devices, drug delivery combinations, interventional devices and the use of novel biomaterials. We have a track record of success over 3 decades and over 20 companies with game-changing medical therapies some of which have become the standard of care such as the first implantable defibrillator. In our current research projects at InCube, the solutions consist of a unique blend of traditional device technologies based on electronics, software, mechanical engineering and material science in combination with pharma-centric disciplines such as physiology, pharmacology, chemistry and protein therapeutics. Having such a broad range of technology and scientific disciplines at its disposal allows InCube Labs to address the most complex, unsolved or poorly treated clinical problems. Examples of our current companies include Neurolink www.neurolinkmedical.com, Corhythm www.corhythm.com, Fe3 www.fe3medical.com, Rani Therapeutics http://ranitherapeutics.com.
San Jose, CA
Thu, 14 Sep 2017 12:56:47 PDT