Lighthouse Lab Services has an exciting opportunity for a Quality Engineer with a Diagnostics business located near Petaluma, CA. In this role, you will responsible for oversight of technical quality assurance primarily focused on the, ensuring that all aspects including facility, equipment test methods, processes, and software, including subsequent changes to them, are validated in compliance with applicable regulation, standards, policies and procedures. This role works closely with all departments especially laboratory operations and IT teams to develop and maintain the site’s validation status. This position will play an important role in the coordination of key validation projects as part of QMS optimization and improvement initiatives. The Quality Engineer is expected to perform their duties with a high degree of independence, reporting to quality and site leadership on the status of validation program and risks.
-Oversee and manage laboratory validation master plan and maintaining the facility in a validated state.
-Collaborate with peers to draft, review and approve validation protocols and reports.
-Provide guidance/training on the use of appropriate statistical techniques and sampling plans with respect to the laboratory and other validations, nonconformance and CAPA programs and other testing protocols.
-Lead teams in root cause analysis of laboratory quality issues. Apply appropriate tools (e.g. statistics, fault tree analysis, etc.) and work with peers to develop corrective action plans.
-Assist in process data collection and analysis to monitor performance of key laboratory processes.
-Support the NC and CAPA processes by performing investigations and root cause analysis, determining action plans and driving the actions to closure.
-Support internal and external audits/inspections as necessary.
-Carry out duties in compliance with established business policies.
-Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
-Prioritizes activities and takes prompt action based on an understanding of quality objectives and business needs.
-Represent the Business unit in Validation Communities of practice.
-Perform other duties & projects as assigned.
BASIC QUALIFICATIONS -Education Bachelor’s Degree or equivalent in Engineering, Chemistry, Bio-Technology, Life Science or related discipline or equivalent combination of education and experience.-3-5 years of experience in a regulated environment such as laboratory or medical device.-Experience with statistical tools including basic statistical inference, graphical methods, regression, DOE, development and sampling plans.-Experience with root cause analysis, failure mode analysis.-Has strong organizational skills, pays close attention to detail and follow-up, and properly balances priorities and resources.-Previous experience contributing to or managing validation projects from the point of inception to completion, including those that require multiple skills.
-Advanced proficiency with Microsoft Suite (Outlook, Word, Excel, Power Point), Database software and Laboratory. Knowledge of Microsoft Project preferred.
-Project coordinator or comparable experience in the healthcare or laboratory industry is desirable.
-Strong written and communication skills
-Six Sigma, ASQ certification preferred.
-Ability to manage multiple projects and competing priorities.
-Maintains a positive attitude, a high level of productivity, and is adaptable to change.
-Demonstrates ability to prioritize, pro-actively work independently and collaboratively with other cross-site employees, across organizational levels, functions, and supports business needs across different time-zones and during periods of heavy workload.
-Ability to work effectively under pressure to meet deadlines.
-Successful candidate must be able to learn new tools and systems in an ever-evolving environment.
At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 15 years of proven success placing job seekers in positions ranging from entry-level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.
It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. Lighthouse Lab Services is committed to working and providing reasonable accommodation to individuals of all abilities, including persons with disabilities. If at any time during the application process, you need an accommodation, please contact email@example.com for assistance.