BD (Becton, Dickinson and Company) Advanced Quality Engineer II (Ops) in Irvine, California
Category: Medical Device
Job ID: 2018-11477
Career Level: experienced
Division: Neomend Ops Plant/Irvine, CA
Location: Irvine,California,United States
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 inin 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:
The Advanced Quality Engineer II (Operations) will lead activities involving product impact assessments for events, product quarantine activities, non-conformance reporting/issue resolution, auditing of production areas, and procedural updates to ensure the process and documentation is compliant with 21CFR820, ISO 13485, and other regulatory requirements as well as internal requirements.
Essential job Functions:
Initiates and leads QA Operations process improvements from start to implementation including creating/revising procedures using the MasterControl Change Control system.
Actively participates in MRB by providing direction and support on the non-conformance process, product impact assessment, root cause analysis, and product quarantine as non-conformances arise. Ensures non-conformance reports are initiated per established requirements and applicable activities are identified and implemented.
Audits personnel and processes in manufacturing areas for practice versus procedures and against current regulatory requirements (FDA, ISO, etc.). Analyze audit results for trends and provide feedback to site management.
Responsible for performing Product Quarantine activities, such as entering product into quarantine, completing quarantine documentation, reviewing/disposition non-conformance records for quarantine release and removal of product from quarantine area.
Leads investigations and corrective action to address out-of-tolerance calibration results, quality events, audit nonconformances, and CAPAs.
Develops or assists in the development of Process Validation documentation such as protocols and reports (IQ, OQ, PQ), executes qualifications, and performs statistical analysis as required.
Creates and executes component qualification protocols and reports
Supports risk management activities including review and development of process FMEAs
Interact in a team environment with Operations, Quality Engineering, Regulatory, and Engineering personnel and participate in project team to help improve the process and increase product quality while keeping within compliance with site Quality Systems procedures.
Lead and/or support other duties as assigned.
Strong Compliance understandingespecially in post-market activities including complaints, failure investigations, nonconforming material and CAPAs.
Experience in Risk Management activities.
Relevant medical device experience.
Applied Knowledge of the requirements of FDA QSR, ISO13485 and ISO 14971.
ASQ certification preferred.
Experience with metrology and/or calibration instrumentation preferred.
Excellent problem solving and project management skills.
Must have a positive attitude with excellent communication, negotiation and interpersonal skills to maintain a team oriented environment.
Ability to thrive under challenging deadlines and in an energetic environment.
Ability to manage multiple projects, communicate updates, and meet milestones in a timely fashion.
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