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Senior QA AssociateSekisui Diagnostics, LLC • United States
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Senior QA Associate

Sekisui Diagnostics, LLC
  • US
    United States
  • US
    United States
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À propos

We're looking for a
Senior Quality Assurance Associate
who enjoys being close to the product, the process, and the people. In this role, you'll be a key contributor to ensuring our finished goods meet quality, regulatory, and customer expectations-while also supporting and strengthening our Quality Management System (QMS).
This is an hands-on, detail-oriented role ideal for someone who thrives in a regulated environment, enjoys cross-functional collaboration, and takes pride in doing things right the first time. If you're someone who can balance day-to-day execution with continuous improvement, we'd love to meet you.
Who are you?
You've got 5+ years of Quality Assurance experience and are comfortable working within a Quality Management System to complete tasks related to document control, training systems, change management, and finished goods release activities, including reviewing DHRs and labeling. You enjoy working with electronic tools like eQMS, DMS, LMS, and DocuSign, and you're known for your strong attention to detail without losing sight of the bigger picture. Most importantly, you communicate clearly, collaborate well across teams, and can juggle multiple priorities while keeping quality, compliance, and continuous improvement top of mind.
What You'll Do
As a Senior QA Associate, you'll play a critical role in both operational quality and system-level support, including:
Perform finished goods QA release, including review of incoming finished goods, Device History Records (DHRs), and inspection results Conduct product labeling reviews, proofing, and first article inspections to ensure accuracy and compliance Maintain training roles and requirements in the electronic Learning Management System (LMS), assign training as needed, including for new hires and retraining needs Support the electronic Quality Management System (eQMS), including documentation revisions and Change Control (CR) processes by appropriately actioning tasks and following up with collaborators to ensure timely completion Consolidate, trend, and summarize quality data to support QA reporting
Additional Details: This is a fully on-site position
SEKISUI offers a competitive compensation and benefits package
The anticipated hourly rate for this position is $30-$33. This role may also qualify for annual incentives and/or 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 what we've always done - focusing on innovating and developing highly accurate diagnostics tests, reagents and 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 worldwide state-of-the-art manufacturing 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 both a regional and product level.
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 to comply with all 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 and encourage candidates 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.
  • United States

Compétences linguistiques

  • English
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