Title: Associate Staff Quality Engineer – Software Development
Location: 130 Baytech Drive San Jose CA 95134
Duration: 9+month Assignment
Shift timings- 1^st shift


Position Summary:
Ensures, through global and local Product Development Process procedures and efforts, that product software are developed, tested and transferred according to established procedures that will assure that they meet all quality requirements.

Responsible to assist in the implementation and maintenance of effective Quality Systems in accordance with FDA Quality Systems Regulation, ISO 9001, ISO 13485 and other applicable country specific regulations. Participates and provides guidance to quality improvement teams on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement.

Primary Duties:

1. Quality Engineering Support for product software Design Control Process –Implement/facilitate product risk management planning as needed. Facilitate and participate in design reviews, develop quality engineering deliverables and assure Design History File (DHF) is updated as necessary.
2. Contribute in the documentation of quality systems and programs in the areas of training, change management, validation, design controls, including product verification and validation, CAPA for relevant design issues, documentation control considerations, etc. to ensure compliance with FDA and regulatory requirements.
3. Serve as contact for assigned program(s) and provide coaching / mentoring to project managers and/or product development team in regard to the product development process, design control (e.g. risk assessment), etc.
4. Review and provide feedback on product documentation to support the product development process.
5. Participate in technical or specialty design review(s) for product development or participate as QA representative in the change management process for product development.
6. Assists in the development and execution of training programs (e.g. change control, risk analysis, Design Controls, etc.).
7. Develop and/or edit standard operating procedures.
8. Prepare for and and support regulatory and agency inspections/audits (ISO/MDSAP/etc.), investigations, and inquiries regarding the control and assessment of product design quality. Support corporate/internal design control audits.
9. Participates in CAPA activities, including investigation, effectiveness, and root cause analysis. Support implementation of corrective actions and preventive measures.

KNOWLEDGE, EXPERIENCE & SKILLS:

1. Requires a minimum of five (5) years experience in a related industry regulated by FDA and/or ISO. - OR - 10+ years directly employed in R&D Quality Assurance of Medical Devices.
2. Requires demonstrated competence in software development processes, and the selection and use of Quality Engineering tools, techniques, and processes.
3. Must have exposure to and knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, IVDR, MDSAP, etc.).
4. Requires effective written and oral communication skills to interact across all levels of the organization.
5. Must have experience in and knowledge of Microsoft Office Package (Word, Excel, etc.).
6. One or more of the following certifications is desired for this role: Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Black Belt.

Additional Job Information:

• This position is responsible to assist in the development of quality programs to facilitate continual improvement actions. Also responsible for assuring product quality and reliability during all phases of product life cycle.
• Must be able to Lift 5-10lbs.
• Excellent Personal Hygiene

Activity Percent of Time (if applicable)

• Bending - n/a
• Walking 25% of Time
• Standing - 25% of Time
• Sitting - 50% of Time
• Typing - 40% of Time