Engineer II, Quality & Organizational Excellence

Work Schedule

Environmental Conditions

Job Description

The Engineer II, Quality is responsible for creating a 1st class quality culture by enabling peer ownership of CAPAs, Quality Plans, Training, and PPI events. This position will drive these items with process owners to ensure timely and effective completion of required activities. Additionally, this role with assist in driving quality excellence through execution of Quality Evolution initiatives, own meaningful quality improvements through Preventive Actions, and develop and monitor quality metrics to create a proactive Quality System.

Location: On-site in West Hills, CA

Key Responsibilities:

• Responsible for administering CAPAs; Coordinate CAPAs by guiding owners in conducting investigations and implementing risk-based corrective actions. Keep track of progress using MasterControl's CAPA module and report metrics to the manager. Implement Preventive Actions to improve quality.

• Responsible for administering Quality Plans (QP); Assist with launching Quality Plans (QP) in MasterControl, review for completeness, enable Impact Assessment reviews, set implementation plans, follow through, review action completion, and report metrics. Responsible for execution of Training Annual Operating Plan (Training AOP); Implement the Training Annual Operating Plan (Training AOP) by choosing appropriate content for effective trainings, establishing schedules, delivering training sessions, and tracking metrics.

• Responsible for Quality participation in Practical Process Improvement (PPI); Ensure Quality participation in Practical Process Improvement (PPI) by attending Tier Board meetings, providing oversight during Kaizen events, ensuring documentation through CAPA generation, and reporting metrics.

Additional support of Quality Department

• Updates of standard operating procedures (SOPs) when necessary.

• Audit participation.

• Execution of Quality Evolution Projects.

Education

• Bachelor’s degree in Biological Sciences or a related field.

​ Experience

• Two (2) years of proven experience in a Quality role in a regulated environment.

• Proficiency in crafting presentations, working with spreadsheets, preparing reports, and documents.

• Proficient in MS Word, Excel, and PowerPoint.

• Background in diagnostics preferred.

Knowledge, Skills, Abilities

• Detailed knowledge of ISO and GMP regulations which govern a medical device and diagnostics manufacturing.

• Familiarity of statistical process controls.

• GMP CAPA requirements.

• Tracking and trending tools and reporting techniques.

• Provide accurate tracking and trending reports.

• Good procedural writing skills.

• Exercise independent discretion and judgment in execution of duties.

• Plan and organize oneself in a consistent manner.

• Be a self-starter with the ability to positively motivate others in a cooperative fashion.

• Establish and maintain effective working relationships with other staff members.

• Effectively communicate both orally and in writing to management, customers and regulatory personnel.

• Maintain confidentiality of sensitive laboratory information; perform computer operations for data entry.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards