Description

Responsibilities:

•\tDesign, develop, and implement quality assurance standard operating procedures and processes for all software products to comply with regulatory bodies.

•\tReview and approve test plans and test cases to ensure that software meets desired quality and performance standards.

•\tIssue test record documents to perform software verification by software test engineer.

•\tDevelop requirement traceability metrics (from user requirements to functional requirements).

•\tReview and approve software documentation for regulatory submission requirements.

•\tFacilitate design input, design lock, software release ceremonies.

•\tReview and approve software related risk documentation (Safety, Security, and Usability)

•\tEstablish metrics to measure quality and performance of existing and new software products.

•\tMonitor and analyze software performance, user feedback, and defects to identify areas for improvement.

•\tWork with product teams to ensure that software meets business and user requirements.

•\tReview verification report at the end of each release

•\tReview Software Bill of Materials (SBOM) to make sure all Software of Unknown Provenance (SOUP) tools or packages are up to date.

•\tOwn software related FDA 510(k) submission documents

•\tParticipate in the design and review of software architecture.

•\tKeep up to date with industry trends and best practices.

Skills

Medical device, FDA Compliance, risk management, software quality management, design control, FDA documentation, diagnostic instruments, procedure writing, audit

Additional Skills & Qualifications

Qualifications & Experience:

•\tBachelor’s Degree or equivalent in Computer Science, Engineering, or related field.

•\tModerate experience in software regulatory environment / medical device software development

•\tStrong knowledge of IEC 62304, IEC 60601, ISO-IEC 80001, ISO 14971, ISO 13485, FDA 21 CFR Part 820.

•\tExcellent decision-making skills, proficient in providing solutions for complex challenges and good problem-solving using quality tools.

•\tExceptional verbal, written and organizational skills and the ability to work effectively in a fast-paced, start-up environment.

Pay and Benefits

The pay range for this position is $90000.00 - $115000.00

Promoting wellness in the workplace and putting our colleague’s wellbeing first is very important to us. Not only to ensure that we have a happy and productive team, but also because we genuinely care. Wellness to us is about having a healthy working environment and offering help and support when things are not so good.

Our Wellness strategy focuses on physical and mental health as well as social and community. We enjoy organising Wellness events for our colleagues; this may include some of the following:

Yoga sessions
Guest speakers that may cover important topics such as managing and avoiding stress or anxiety, using breathing techniques and many more
Company Wellness Weeks with lots of fun activities and insightful advice
Financial advice
Employee Assist Program with confidential 3rd party advice
Social events to promote supportive relationships
We also have a team of Mental Health First Aiders, the team are from all different departments and levels across the company.

They have been professionally trained to deal with a multitude of difficult and serious situations. They are also just there sometimes to lend and ear and listen.

We understand that wellbeing and support is high on the list for our colleagues and potential candidates, we therefore strive to continuously flourish and grow in this area.

Workplace Type

This is a fully onsite position in CARLSBAD,CA.

Application Deadline

This position will be accepting applications until Jan 21, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.