Quality Assurance Specialist

2 weeks ago

Beverly Hills, California, United States Goddard Inc. Full time
Join Our Team as a Quality Assurance Specialist


As a vital member of our organization, you will contribute significantly to the assurance that our products are developed in alignment with industry standards, regulations, and engineering best practices.

Your role will be essential in our expanding Quality Assurance and Verification & Validation team, ensuring the integrity and dependability of our work while impacting products that can save lives.


Key Responsibilities:


• Develop, implement, and sustain quality assurance processes, systems, and documentation to guarantee adherence to regulatory requirements such as FDA and ISO 13485.
• Lead initiatives aimed at process enhancement.
• Conduct root cause analysis and manage corrective and preventive actions (CAPA) for non-conformances and customer feedback related to software design challenges.
• Oversee supplier quality management, including performing audits of subcontractors and component suppliers.
• Create and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.

• Collaborate with cross-functional teams, including Research & Development, manufacturing, and regulatory affairs, to ensure quality considerations are integrated throughout the product lifecycle.

• Perform additional duties as assigned.


Qualifications:


• A minimum of 5 years of direct experience with FDA Quality System Regulations and ISO 13485 in a Quality Engineering capacity.
• A Bachelor’s degree in Mechanical, Biomedical, Electrical, Software, or Systems Engineering, or a related field, or equivalent professional experience.
• Experience in software validation, product development, and new product introduction (NPI) within the medical device sector.
• Familiarity with relevant medical device regulatory standards such as FDA 21CFR 820, ISO 13485, IEC 62304, IEC 60601, ISO 14971, etc.


Preferred Skills:
• Proficiency in SolidWorks CAD.
• Demonstrated expertise in statistical data analysis methods and tools, such as Gage R&R, Hypothesis Testing, Tolerance Interval Analysis, Acceptance Sampling, and statistical process control using software like Minitab, JASP, or SAS.


Knowledge, Skills, and Abilities:


• Excellent verbal and written communication skills.
• Ability to effectively manage and prioritize multiple ongoing projects and tasks (Project Management skills).
• Strong collaborative skills, both within the function and across other departments.
• Exceptional interpersonal skills, capable of working independently and as part of a team.
• Self-motivated, results-oriented, and detail-focused.


Working Environment:


Goddard is a professional services organization specializing in product development and contracting. Travel to client sites may be required to support project needs, typically within a short commute from the company location. This position offers a hybrid work model, with an expectation of at least 3 days in the office and 2 days working remotely.


Our Benefits:


Competitive Compensation:
Receive a comprehensive rewards package that includes a competitive salary, bonuses, benefits, and opportunities for professional growth.

Flexible Time Off:
Enjoy well-deserved rest and relaxation with our flexible time-off schedule and 10 paid holidays.

Retirement Savings:
Invest in your future with a 401(k) retirement plan that includes profit-sharing contributions.

Health Coverage:
Access comprehensive medical, dental, and vision insurance for you and your family.

Family Support:
We support family growth with 6 weeks of fully paid parental leave, complemented by state programs.

Community Engagement:
Connect with colleagues through regular company and team events, such as social hours and local celebrations.


Goddard Technologies, Inc. is an equal opportunity employer. We embrace diversity and are committed to creating an inclusive environment for all employees.

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