BD (Becton, Dickinson and Company) Quality System Engineer in Irvine, California
Job Description Summary
BD Interventional’s Surgery business unit is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. We have stood out as the market leader in providing solutions in soft tissue reconstruction including products for hernia repair, specialized surgical procedures, fixation and biologic implants. In addition to this extensive suite of products, our BioSurgery business is delivering a growing line of enhanced sealants and hemostatic products to complement surgical techniques across, thoracic, cardiovascular and other surgical specialties.
Our company has a strong tradition of developing our employees to learn, grow and excel. We are continually building our team with qualified, team oriented individuals to enhance the success of our company.
The Irvine plant is situated in the heart of Orange County with easy access to the expansive coastline, John Wayne Airport, Amtrak and Metrolink. Our office is within a 20 minute drive to local attractions including Laguna, Huntington and Newport beaches, Disneyland, Los Angeles Angels Stadium, the Honda Center of Anaheim, and is just a short distance to San Diego and Los Angeles.
Summary of Position with General Responsibilities:
Supports Quality Compliance functions within QA.Establishes and manages the necessary quality programs to ensure the Company meets the Quality System requirements per company procedures and applicable federal regulations and international standards
Essential job Functions:
Plans, coordinates, conducts and participates in internal and external scheduled and ad hoc Quality System audits to assess the compliance with FDA regulations, ISO standards, MDD and any other international regulations and internal requirements
Audit results reporting, analysis and presentation of audit findings. Perform follow up and tracking of audits to verify that corrective action has been taken and is effective in preventing recurrence.
Oversee the corrective and preventive action system (CAPA) and analyzing the results of the implemented actions in order to verify that the realized solutions were effective and determine if the scope of the action is broad enough.
Maintain systems for tracking CAPAs and Audit findings and perform trending activities and provide information as appropriate to management.
Oversees the environmental monitoring program by analyzing data and reporting on trends and coordinating investigation as required.
Participates in the Material Review Board meetings and takes the lead with other functional groups to determine root cause failure and implement actions to prevent recurrence.
Leads Quality Engineering Projects to improve Quality System and Procedures (e.g., defect analysis, control charts, data analysis, lead Quality and Continuous Improvement Projects).
Oversees the generation, publishing, trending, and monitoring of Quality metrics
Monitors quality trends and conducts technical and statistical investigations on quality problems, reporting the results and recommendations in a timely manner.
Provide routine reports including trends of sterilization or biologic monitoring results.
Performs special projects and other duties as assigned.
B.S. Degree in Engineering or Technical Science with 5-8 years relevant experience or M.S. Degree in Engineering or Technical Science with 4-6 years relevant experience.
Strong Compliance understanding especially in post-market activities (including complaints, failure investigations, and CAPAs).
Relevant medical device experience.
Applied Knowledge of the requirements of FDA QSR, ISO13485:2016 and ISO 14971:2012.
ASQ CQE certification preferred.
Microbiology experience preferred
Experience with combination products and absorbable technologies preferred.
Excellent problem solving, interpersonal communication, presentation, statistical analytical, computer, and project management skills
A high level of competence in Quality Technology, statistical techniques, and six sigma tools including: sampling plans, process capability analysis, gage R&R, hypothesis testing, analysis of variance, regression, and design of experiments.
Must have a positive attitude with excellent communication, negotiation and interpersonal skills to maintain a team oriented environment and maintain critical relationships with contractors, suppliers and investors.
Ability to thrive under challenging deadlines and in an energetic environment.
Must have a desire for achieving excellence in customer satisfaction, process and product quality and reliability.
Ability to manage multiple projects, communicate updates, and meet milestones in a timely fashion.
Work Environment/Demands of the Position:
Travel – Approximately 10% of work time will be spent traveling.
Physical Demand –The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time.Occasionally the employee will be required to lift or move at least 50 pounds.
Mental Demand – Moderate to high degree of concentration due to volume, complexity, and/or “pressure” of work.Expected to meet project deliverables that may require significant time commitments and support.
BD Interventional and Becton Dickinson are Affirmative Action/Equal Opportunity Employers, M/F/D/V. VEVRAA Federal Contractor.
Primary Work LocationUSA CA - Irvine Neomend
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status