QA Specialist

SEKISUI Diagnostics; San Diego (CA); Presencial; USD 87 000 - 100 000; Tempo integral

Resumo da oferta

SEKISUI Diagnostics, LLC is seeking a QA Specialist to strengthen our Quality Management System and ensure compliance across deviations, CAPAs, change control, audits, and validations. You will partner with R&D, Operations, and cross-functional teams to drive continuous improvement and robust quality practices.

With 5+ years of QA experience in a regulated environment and knowledge of 21 CFR Part 820, ISO 13485, and FDA medical device requirements, you will help maintain compliance while

Qualificações

• 5+ years of Quality Assurance experience in a regulated environment.
• Experience with 21 CFR Part 820, ISO 13485 & FDA medical device requirements.
• Experience with deviations, CAPAs, change control, audits, equipment management, and validation.
• Strong problem-solving skills to assess nonconformities and implement effective solutions.
• Ability to manage multiple priorities and projects.
• Strong communication and interpersonal skills; ability to navigate challenging situations.
• Collaborative, customer-focused approach with ability to work independently and across teams.

Responsabilidades

• Review deviations and CAPAs from a QA perspective.
• Review and approve change requests related to controlled documentation.
• Plan and perform internal compliance audits.
• Participate in or conduct external supplier audits.
• Review and approve validation protocols and summary reports.
• Generate and analyze quality data and trends to identify opportunities for improvement.
• Maintain and support the QMS (CATSWeb).
• Provide QA support and oversight to cross-functional project teams, including R&D and Operations.
• Partner with colleagues to address quality concerns and maintain compliance with established requirements.

Conhecimentos

Quality Assurance

Regulated environment

Problem solving

Communication

Collaboration

Ferramentas

CATSWeb

Descrição da oferta de emprego

Are you passionate about quality, compliance, and finding practical solutions in a regulated environment? We’re looking for a QA Specialist who can bring strong Quality Systems knowledge, sound judgment, and a collaborative mindset to our team.

In this role, you’ll partner across functions to help ensure our processes, documentation, and products meet applicable quality and regulatory requirements. You’ll have the opportunity to work on everything from deviations and CAPAs to audits, validations, Quality System improvements, and cross-functional projects.

Who You Are

You’re a quality professional who understands that Quality Assurance is more than checking a box. You’re comfortable asking questions, evaluating risk, solving problems, and partnering with others to find the right path forward. You’re a collaborative, solutions-focused quality professional who brings sound judgment, strong technical knowledge, and a practical approach to maintaining compliance.

• 5+ years of relevant Quality Assurance experience preferred
• Experience in a regulated environment, with knowledge of 21 CFR Part 820, ISO 13485 & FDA medical device requirements
• Experience with deviations, CAPAs, change control, audits, equipment management, and validation
• Strong problem-solving skills with the ability to assess nonconformities and recommend effective solutions
• Ability to successfully manage multiple priorities and projects
• Strong communication and interpersonal skills, including the ability to navigate challenging situations
• A collaborative, customer-focused approach with the ability to work independently and across teams

What You’ll Do

As a QA Specialist, you’ll play an important role in maintaining and strengthening our Quality Management System. Depending on business needs, your responsibilities may include:

• Review deviations and CAPA’s from a Quality Assurance perspective
• Review and approve change requests related to controlled documentation
• Plan and perform internal compliance audits
• Participate in or conduct external supplier audits
• Review and approve validation protocols and summary reports
• Generate and analyze quality data and trends to help identify opportunities for improvement
• Maintain and support the QMS (CATSWeb)
• Provide QA support and oversight to cross-functional project teams, including R&D and Operations
• Partner with colleagues to address quality concerns and help maintain compliance with established requirements

Quality touches every part of what we do. As a QA Specialist, you’ll have the opportunity to work across the organization, influence quality practices, identify opportunities for improvement, and help ensure we continue to meet the standards our customers and patients depend on.

If you’re looking for a role where you can apply your quality expertise while collaborating with a variety of teams and making a meaningful impact, we’d love to hear from you.

NOTE: This Role requires onsite presence 4 days a week.

SEKISUI offers a competitive compensation and benefits package

This is an exempt position; theanticipatedcompensation is $87,000-$100,000 Annually. This role also qualifies for annual incentives and comprehensive benefits. The actual base salary offered will depend on a variety of factors, including without limitation, the qualifications of the individual applicant for the position, years of relevant experience, level of education attained, certifications or other professional licenses held, and if applicable, the location of the position.

ABOUT US:

At SEKISUI Diagnostics, we help improve patient outcomes by doing whatwe’vealways done – focusing on innovating and developing highlyaccuratediagnostics tests,reagentsand systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwidestate-of-the-artmanufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers – and customize solutions at botha regionaland productlevel.

As an equal opportunity employer, SEKISUI Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job-related characteristics or other prohibited grounds specified in applicable country and local laws. It is also SEKISUI Diagnostics policy tocomply withall applicable country and local laws respecting consideration of unemployment status in making hiring decisions.

SEKISUI Diagnostics is pleased to consider all qualified applicants for open roles andencouragecandidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company’s internal recruiting team.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.