Position: Sr. Software Quality Engineer, Req#: 5509-1
Location: Irvine, CA (100% onsite)
Duration: 6 Months Contract

Job Description: 

The main function of this Sr. Software Quality Engineer is to lead all software engineering activities relating to the validations of several production equipment with custom software. The main purpose of this role is to apply knowledge of software quality engineering to assess risk, execute validation activities, and develop/approve software documents.

Education and Experience: 

• Bachelor's degree in Engineering with a minimum of 5 years of experience, or Master's degree in Engineering with a minimum of 4 years of experience.
• Previous experience with software verification and validation activities in the medical device industry.

Must Haves:

Experience in product software validation for manufacturing equipment with custom or modified Commercial Off-the-shelf software. Authored software validation protocols, software hazard analysis, and software validation reports for custom manufacturing equipment. Collaborate to perform software code reviews for product software or custom manufacturing equipment. Perform dry runs on software validation protocols.

Nice To Have:

Experience in leading Non-Conformance Report (NCR) from start to finish, including root cause analysis skills and implementation of correction or corrective actions.

Must Haves (with medical device equipment):

• Investigate complex product / non-product software quality and compliance issues (e.g. software deviations/failures) for all production processes before final product release based on engineering principles; analyze results, make recommendations, and develop reports.
• Assess Risk Management activities including authoring of Software Hazard Analysis for complex projects/systems / test equipment in partnership with cross-functional teams; provide recommendations for improvements.
• Develop complex software documentation (e.g. Protocols, Reports, Hazard Analysis) for product or non-product software validation deliverables utilizing engineering knowledge.
• Collaborate with stakeholders on the Code Review process for product software or custom manufacturing test equipment.
• Perform dry-runs and execution of Software Validation Protocols.

Nice To Haves:

• Experience in leading Non-Conformance Report (NCR) from start to finish, including root cause analysis skills and implementation of correction or corrective actions.

Required Skills: 

• Proven expertise in the usage of MS Office Suite;
• Strong documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills.
• Working knowledge and understanding of statistical techniques.
• Substantial understanding and knowledge of principles, theories, and concepts relevant to the Software Development Lifecycle related to Software Quality Engineering (e.g., CQE body of knowledge) for product and non-product software.
• Substantial knowledge of business acumen products and software technologies
• Strong problem-solving, organizational, analytical, and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of and adherence to related procedures (e.g., Cybersecurity procedures related to IT systems, manufacturing equipment, or product software).
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control.

Level of Independence:

• Works independently without close supervision.
• Compares and evaluates possible courses of action after considering various possibilities.
• Applies knowledge in following procedures or in determining which procedures to follow or determining whether specified standards are met.
• Considers the cause and effect of activities.
• Determines or effectively recommends a course of action after considering potential risks of alternatives.
• Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive.

Roles and Responsibilities: 

• Investigate complex product / non-product software quality and compliance issues (e.g. software deviations/failures) for all production processes before final product release based on engineering principles; analyze results, make recommendations, and develop reports.
• Assess Risk Management activities including authoring of Software Hazard Analysis for complex projects/systems/test equipment in partnership with cross-functional teams; provide recommendations for improvements.
• Develop complex software documentation (e.g. Protocols, Reports, Hazard Analysis) for product or non-product software validation deliverables utilizing engineering knowledge.
• Collaborate with stakeholders on the Code Review process for product software or custom manufacturing test equipment.
• Perform dry-runs and execution of Software Validation Protocols.
• Train, coach, and guide other employees on software documentation.
• Other Incidental duties as required.

About the Company:
TalentBurst, Inc.

TalentBurst is an award winning IT and Accounting & Finance staffing firm headquartered in Boston with branch offices in San Francisco, Miami, Milwaukee, Toronto, Bangalore, and Gurgaon. Our clients include the leading social media, technology, banks, utilities, pharmaceutical, and biotech companies.
We work with 75 of the Fortune 500 companies and work on 2,000 new job requisitions per month. Our recruiting team is one of the most successful in the industry. We have a strong reputation for treating our employees well and helping you find your next dream employer. BenefitsAt TalentBurst, one of our founding principles has been to provide our employees with the best benefits available. To adhere to this principle, we have a broad benefits offering. Our recruiters are dedicated to connecting you with awesome career growth opportunities with leading companies.

Company Size:
5,000 to 9,999 employees

Industry:
Staffing/Employment Agencies

Founded:
2002

Website:
http://www.talentburst.com/