- 180637 - Quality Engineer II
- CA-Bay Area
- 6 Months
- Chipton-Ross is seeking a Quality Engineer II for an opening in Pleasanton, CA.
The Quality Engineer will responsible for providing site QA support including audit readiness, audit hosting & logistics, identifying and implementing improvements, collection and reporting on Management metrics, preparing management presentations, analyzing and reporting data, reviewing and approving documents including COAs and SOPs or work instructions.
Assure compliance to internal SOPs and other regulations
Participate in and lead internal audits per ISO 13485 and 9001 requirements and ensure site audit readiness; participate in third party audits and FDA inspections as needed and support internal activities concerning any identified nonconformities
Follow up on complaints, including approval of investigations, provide trending and escalations as appropriate
Assist in audits from external customers
Prepare Management Review and quality metrics
Ensure CAPAs are identified and ensure timely resolution of quality problems; review and approve CAPAs
Promote and implement improvements and compliance with site Quality Management System requirements
Participate in departmental projects and improvement initiatives, streamline SOPs and processes, work with other groups to continuously improve
Support continuous improvements through participation within the Site’s PPI Program
Prepare clearly written business communications, including audit reports, gap assessments, validations, etc.
Support creation of training as needed, update training plans and databases
Serve as backup for other Quality personnel and functions as needed
Collaborate and communicate both vertically and horizontally in a way that commands both personal respect and mission acceptance
Write, review, analyze and revise written relevant Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Site, Regulatory Requirements as directed;
Assist in trending data to look for ways to improve quality processes.
Creating Certificates of Assurance for products managed by the site
Perform other duties to support the quality and regulatory department as assigned.
Experienced working in ISO 9001, 13485 and/or GMP environment
2 – 5 years of work experience in Quality role, either as QA, QS
Strong computer skills (Office, Project, Teams, Visio, Word, Excel) with experience with SAP, Agile, and TrackWise
Experience with Quality tools, methodologies, and complaint investigations
Highly energetic, positive attitude, works well under stress
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;
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;
High level of reading comprehension skills;
Must be able to read, write, and speak English.
Accredited Bachelor’s degree in life sciences, engineering, process engineering, chemistry, biotechnology or related sciences
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.