A large global medical device company is looking to identify a Complaint Quality Engineer II to perform failure investigations and lead engineering evaluation for customer complaints for Critical Care's Medical Device products. We are looking for a strong engineer with complaint investigation experience who enjoys working in a fast-paced and rapidly growing environment to reduce product complaints and improve manufacturing methods using engineering principles.
Essential Job Functions:
• Investigate complex product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
• Participate in and own escalation tasks and activities, including Project Risk Assessments (PRAs) and Corrective/Preventive action(s) (CAPAs) as determination by investigation.
• Identify and report key complaint metrics per device category and collaborate with applicable Clinicians, Manufacturing Engineering, R&D, sustaining engineering teams to investigate and resolve device related issues.
• Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.
• Support development of moderately complex experiments and tests (including writing and executing protocols) to investigate issues and improve products and manufacturing methods based on engineering principles; analyze results, make recommendations, and develop reports.
• Substantial understanding and knowledge of principles, theories, and concepts relevant to EMI/EMC hardware and software knowledge within circuitry level (PCB level) as well as system.
• Knowledge of regulatory requirements, e.g. FDA, IEC, CE, ISO, IEEE
• Complaints investigation experience and/or hands-on experience with device investigations using quality tools to include 5 Whys, 6 M, Ishikawa Diagram, Pareto Charts, and CAPA;
• Knowledge in statistical theory and application, able to perform capability studies on product failures and review trends and propose improvement upon stats trends.
• Demonstrated experience by applying risk management tools (FMEA) to solve complex problems
• Strong written and verbal communication skills
• Must have Medical Device or Pharmaceutical experience with GMP and ISO regulation including ISO 13485, ISO-14971, IEC 60601, MDD and EU MDR.
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Strong problem-solving, organizational, analytical, and critical thinking skills (strict attention to detail)
• Basic understanding of statistical techniques
• Ability to interact professionally with all organizational levels and manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on projects
Education & Experience:
• Bachelor's Degree in Mechanical Engineering, Electrical Engineering or related engineering field with 3 years of experience in Quality Engineering or Quality Assurance.
• Master's Degree or equivalent and internship, senior projects, or thesis in Engineering field including relevant industry experience or combined industry/education experience required
• Experience within life science industry and working under an FDA regulated environment Experience in conducting root cause investigation and prepare reports, for negative trends of process or product failures or critical characteristics not being met.
We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.