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Senior software quality assurance engineer

BioSig Technologies, Inc.

This is a Full-time position in Los Angeles, CA posted December 31, 2019.

JOB SUMMARY The Sr.

Software QA Engineer will report to the Software QA Manager working to ensure quality assurance of products working within the governance of the Quality System.

The incumbent will lead software and system design reviews at each stage gate in the design control process and follows 21 CFR 820, ISO 13485, ISO 14971, MDD 93/42/EEC standards.

Incumbent must be a team player who enjoys problem solving and should be well organized.

KEY RESPONSIBILITIES 1.

Working within a cross-functional team with hardware and software engineers engaged in Software QA activities in an FDA-Regulated Class II device environment 2.

Ensure the quality of the software systems, validate software requirements ensuring full traceability.

3.

Participate in the design and development through product test of software platform through each design control phase and product lifecycle.

4.

Verification and Validation activities, design reviews, unit testing, risk management and FMEA development and review.

5.

Interface with Software Development Engineers to transfer software from research into product development process.

6.

Manage Bug Tracking System and Software Change Control Board meetings.

7.

Manage software related product development and design history file activities.

8.

Generate ISO 62304 compliant documentation, perform software verification and validation activities.

REVELANT EDUCATION AND TRAINING REQUIRED B.S.

or M.S.

degree in Software, Biomedical or Electrical Engineering, Physics or Computer Science or equivalent with 3-5 years of relevant experience.

Minimum three years related experience in the medical device industry.

Experience with electrical medical devices a plus.

KNOWLEDGE AND SKILLS REQUIRED
· Knowledge of Quality System Regulations, ISO Standards, GMP and GLP.

· Experience and knowledge in design verification and process validation techniques.

· Strong understanding of identification and traceability requirements throughout all stages of the design and manufacturing processes.

· Experience working in a regulated medical industry environment required
· Vendor and contract management experience
· Solid understanding of HIPAA and GDPR compliance practices
· Understanding of Software Development Life Cycle
· Strong organizational, verbal and written communication skills
· System level risk management reviews and Failure Mode and Effects Analysis
· Verification and validation testing
· Software testing oversight
· Software bug tracking and defect disposition
· Product performance reviews
· Perform design review meetings
· CAPA management
· DHF audit management
· Strong written and verbal communication skills to convey details and analytical problem solving solutions