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.
About You:
Your strong analytic and critical thinking skills are key to your solution-oriented approach to integrating quality into the teams you work with. You lead activities with focus on meeting business goals by driving quality improvements, proactively addressing risk, and staying at the forefront of trends and new developments in diagnostics. Your experience with Point of Care & Molecular IVD devices will bring value as you work cross-functionally (R&D, regulatory, quality compliance) to bring quality diagnostic products to the market.
As Principal QA Engineer, you will showcase your 12+ years of quality expertise by analyzing, implementing, and validating processes and solutions to drive quality throughout the life-cycle management of our molecular and point of care devices. No two days will be the same as you work in a fast-paced environment focused on continuous improvement. Your experience will be evident in the way you:
- Lead the validation program by developing and maintaining the site master validation plan and coordinate validation activities for equipment, processes and software systems
- Support New Product Development, including assay, instrumentation and software by implementing design controls and by reviewing and implementing process change requests
- Collaborate with cross-functional stakeholders to lead complex investigations and implement robust corrective actions to ensure good manufacturing practices; and collaborate with 3rd party suppliers and/or contract manufacturers as you visit sites to ensure productive relationships are established and maintained
This is an on-site role with 20% or less travel anticipated.
SEKISUI offers a competitive compensation and benefits package.
The anticipated base salary for this position is $130,000-$145,000. 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
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 encourages 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.