The role of the Quality Engineer is to support, strengthen and advance the Quality mission, which is enabling our customers to make the world healthier, cleaner and safer by continuously improving the quality of our products and services. The Quality Engineer will work with various team members, both internal and external customers, with a high degree of professionalism. This is a very hands-on role and works collaboratively with other departments.
What will you do?
As a QA Engineer, you will help provide support to ensure the Pleasanton site meets all the requirements for ISO 9001 and 13485. You can help make an impact by providing site QA support including audit readiness, audit hosting & logistics, helping drive continuous improvements, collection and reporting on complaint and CAPA metrics, preparing management presentations, analyzing investigations and data to ensure appropriate measures are in place to maintain systems compliance.
- Primary duties will include complaint handling, will work with cross functional department on complaint cases for investigations, root cause analysis, and corrections/corrective actions to ensure proper documentation and closure, provide trending and escalations as appropriate
- Analyze and trend all types of data (CAPA, problem records, complaints, on market surveillance) to identify deficient areas and initiate quality improvement projects
- Engage with internal and external customers on Quality agreements and change notification agreements
- Participate in and lead internal audits per ISO 13485 and 9001 requirements and ensure site audit readiness
- Participate in third party audits, external customers and Agency inspections as needed and support internal activities concerning any identified nonconformities
- Participate in external audits of Pleasanton’s suppliers as needed
- Write, review, and approve CAPAs to ensure timely resolution of quality problems
- Support creation of training plans and update training database to maintain compliance
- Promote and implement improvements and compliance with site Quality Management System requirements
- Participate in departmental projects and improvement initiatives through the site’s PPI Program and partner with other groups to continuously improve
- Prepare clearly written business communications, including audit reports, gap assessments, validations, etc.
- Write, review, analyze and revise written relevant Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Site, Regulatory Requirements as directed;
- Serve as backup for Quality team leader or Manager as needed
- Perform other duties to support the quality and regulatory department as assigned.
How will you get here?
Bachelor’s degree in life sciences, engineering, process engineering, chemistry, biotechnology or related sciences
- Experienced working in ISO 9001, 13485 and/or GMP environment
- 5+ years of work experience in Quality Assurance/Systems/Engineer role
- Strong computer skills (Office, Project, Teams, Visio, Word, Excel) with experience with SAP, Agile, and TrackWise, Power BI
- Experienced with Quality tools, methodologies, and complaint investigations, including root cause analysis
- Experienced in improving site’s Quality Management System and promoting site Quality
- Experienced working & collaborating with internal and external customers
- Experience with Post Market Surveillance
Knowledge, Skills, Abilities
- Must be self-motivated, organized, detail oriented, and have ability to complete projects and assignment and be comfortable to work under minimal supervision, independently, and work with a diverse team
- Strong analytical and problem-solving skills with attention to details and the ability to find creative solutions that meet regulatory and business requirements
- Solid organizational skills with ability to balance complex and routine work activities and competing priorities and the ability to manage time effectively and prioritize work
- Highly energetic, positive attitude, works well under stress
- Excellent communication and interpersonal skills with the ability to interact with all levels of the organization both orally and in writing; strong track record of working cross functionally
- Ability to work in teams and independently to obtain results as required; including ability to resolve quality related issues in a timely and effective manner
- High level of reading comprehension skills
- Results oriented, make sound business decisions and multi-tasking skills are a must
- Must demonstrate strong organizational skills and attention to details