BD · 2 weeks ago
Complaint Specialist
USA TX - El Paso - Northwestern Dr.
Full-time
Onsite
Entry, Mid Level
2+ years expBD is one of the largest global medical technology companies in the world. This role provides support to the entire product complaint process, ensuring compliance with global regulations and leading customer complaint investigations while collaborating cross-functionally with various departments.
Health CareMedical DeviceTechnical Support
Responsibilities
Providing direction and management for the complaint processing team, ensuring all complaints are handled according to established Standard Operating Procedures (SOPs) and global regulatory requirements
Overseeing and conducting product complaint investigations, which involves gathering information, coordinating sample returns for evaluation, and determining the root cause
Assessing complaints to determine if they are reportable events (e.g., adverse events, medical device reports [MDRs]) and ensuring timely submission to appropriate regulatory agencies like the FDA
Ensuring accurate and detailed records of all complaint investigations and resolutions are maintained in the Quality Management System (QMS) database
Performing analysis and trending of complaint data to identify recurring issues, potential risks, and areas for continuous improvement
Partnering with internal departments (R&D, Manufacturing, Supply Chain, etc.) and external Contract Manufacturing Organizations (CMOs) to address and resolve complex issues
Serving as the Subject Matter Expert (SME) for the complaint process during internal and external audits and regulatory inspections
Coaching, training, and mentoring team members on complaint handling processes and procedures, fostering a culture of compliance and excellence
Identifying areas for process improvement and leading initiatives or participating in CAPA (Corrective and Preventive Action) activities related to complaint findings
Qualification
Required
Bachelor's Degree required (preferably within the Sciences, Engineering, or Clinical fields.)
2-4 years of complaint handling, post market surveillance, or quality system experience in medical device industry (required)
Previous experience conducting or leading root cause investigations
Demonstrated leadership and communication skills with strong attention to detail
Preferred
Advanced degree in a scientific or related discipline preferred
Pharma industry experience preferred
Previous experience presenting during internal or external audits (preferred)
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Maureen Mazurek
Chief Sustainability and EHS Officer
Recent News
EIN Presswire
2026-01-09
Company data provided by crunchbase