Sr Quality and Complaints Eng

Orlando Health•Orlando, FL

8d•Hybrid

About The Position

At Orlando Health, we are ordinary people with extraordinary individuality, working together to bring help, healing and hope to those we serve. By daily embodying our over 100-year legacy, we reinforce our reputation as a trusted and respected healthcare organization that delivers professional and compassionate care to our patients, families and communities. Through our award-winning hospitals and ERs, specialty institutes, urgent care centers, primary care practices and outpatient facilities, our 27,000+ team members serve communities that span Florida’s east to west coasts and beyond. ORLANDO HEALTH - BENEFITS & PERKS: All Inclusive Benefits (start day one) Student loan repayment, tuition reimbursement, FREE college education programs, retirement savings, paid paternity leave, fertility benefits, back up elder and childcare, pet insurance, PTO/Holidays, and more for full time and part time employees. Forbes Recognizes Orlando Health as a Best-In-State Employer Forbes has named Orlando Health as one of America's Best-In-State Employers for 2024. Orlando Health is the top healthcare organization in the Metro Orlando area to make the prestigious list. "We are proud to be named once again as a best place to work," said Karen Frenier, VP (HR). "This achievement reflects our positive culture and efforts to ensure that all team members feel respected, supported and valued. Employee-centric Orlando Health has been selected as one of the “Best Places to Work in Healthcare” by Modern Healthcare Position Overview This role oversees and leads complaint handling activities and supports critical quality engineering functions, including Design History File (DHF) management, supplier audits, and management of the Electronic Quality Management System (eQMS).

Requirements

Bachelor’s degree in engineering, life sciences, or a related technical field.
Seven (7) years of Quality Engineering experience in the medical device industry.
Strong working knowledge of: o Complaint handling and CAPA systems o Design Control and DHF compliance o Supplier quality management and auditing o QMS standards: FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR

Nice To Haves

ASQ certifications (CQE, CQA, etc.) preferred.

Responsibilities

Leads end-to-end complaints handling processes, including intake, triage, investigation, documentation, root cause analysis, and resolution.
Collaborates with cross-functional teams to ensure timely closure of complaint records and implementation of effective corrective/preventive actions (CAPAs).
Analyzes trends in complaints to identify systemic issues and opportunities for product or process improvements.
Supports regulatory reporting requirements (e.g., FDA eMDR, EU Vigilance, etc.) and ensures documentation is complete and audit ready.
Reviews and ensures completeness, accuracy, and regulatory compliance of DHFs throughout the product development lifecycle.
Provides quality engineering input during design reviews, risk management (ISO 14971), and validation/verification activities.
Supports Design Control processes in accordance with FDA 21 CFR 820 and ISO 13485 standards.
Demonstrates proficiency in risk management and statistical analysis tools (e.g., Minitab)
Conducts and supports supplier qualification, audits, and ongoing performance monitoring.
Collaborates with Procurement and Engineering to resolve supplier-related quality issues, nonconformances, and SCARs.
Ensures supplier compliance with applicable regulatory and quality requirements.
Supports continuous improvement and maintenance of the eQMS in compliance with FDA, ISO 13485, EU MDR, and MDSAP.
Leads or contributes to internal audits, management reviews, and QMS documentation updates.
Develops and tracks quality metrics and key performance indicators (KPIs).
Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state and local standards.
Maintains compliance with all Orlando Health policies and procedures.
Prepares and presents quality reports, CAPA updates, and complaint metrics to senior management.
Mentors junior engineers and quality staff.
Acts as SME during regulatory inspections and notified body audits