Quality Engineer/Trainee Engineer

JOB TITLE: Quality Engineer/Trainee Engineer

Department: Global Complaint Management

JOB SUMMARY

Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making minor adaptations and modifications. Assignments include Quality Process execution, research for investigations, report preparation and other activities of limited scope. Duties are assigned to provide experience and familiarization with quality, compliance and engineering methods, independent thinking, and company practices and policies.

ESSENTIAL DUTIES

• Investigation and co-ordination of customer product quality complaints both Normal priority and High Priority .
• Prepares Medical Device Reports/Adverse Event Reports(MDRs/AERs) adhering to FDA regulations in a timely manner.
• Enters complaint and routine service records both manually and by uploading spreadsheets into the quality system application .
• Provide accurate and timely turn-around on complaints and other activities. Maintain records that are accurate and concise.
• Generates Customer Feedback Letters extracted from Complaint Investigation and effectively collaborate with other teams to the answer the queries raised by customer.
• Prepares and reviews engineering/technical documents such as Reports, SOPs, Work Instructions and process documents.
• Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives and recommending solutions.
• Follows department processes and regularly makes recommendations on these processes.
• Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.
• Actively participates in Quality System and Good Laboratory Practice requirements, particularly with respect to documentation.
• Run trends from established database for communication or product improvement activities.
• Demonstrate extreme focus to the end customer.
• Run trends from established database for communication or product improvement activities.
• NEW: Performs complaint review, classification, prioritization, triage, and escalation assessments based on product risk and regulatory requirements.
• NEW: Conducts and documents root cause investigations using 5-Why Analysis, Fishbone Analysis, Fault Tree Analysis, and Failure Mode Analysis techniques
• NEW: Reviews returned product evaluations, failure analysis results, and device inspection findings to support investigation conclusions.
• NEW: Supports ISO 14971 risk management activities including hazard identification, risk evaluation, and risk file updates resulting from complaint investigations.
• NEW: Supports Post-Market Surveillance (PMS) activities through complaint trending, signal detection, and adverse event monitoring.
• NEW: Identifies and escalates complaint investigation outputs requiring CAPA initiation and supports CAPA effectiveness activities.
• NEW: Ensures complaint handling compliance with 21 CFR 820 complaint requirements, MDR regulations, ISO 13485, EU MDR vigilance, and applicable global regulations.
• NEW: Performs complaint data analytics and statistical trending to identify recurring issues, emerging signals, and product improvement opportunities.
• NEW: Collaborates with Manufacturing, Engineering, Regulatory Affairs, Clinical, Supplier Quality, and other SMEs during complex investigations.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelor Degree in Engineering (preferably Mechanical/Electrical/Electronics)

Experience

• Preferably min one year experience in medical device manufacturing environment and/or previous experience in Post Market Compliance

Skills

• Knowledge and use of relevant PC software applications like SAP, Windchill, Salesforce and skills to use them effectively. Exposure to Excel, Word, SharePoint and Teams.
• Excellent interpersonal and communication (written and verbal) skills from a global perspective.
• Must be able to translate or have translated by local representation, all regional complaints and routine service reports into technically accurate English text
• Demonstrated ability to routinely diagnose problems and recommend solutions through teamwork, failure mode analysis, and other analytical techniques.
• Self-directed individual with the ability to perform essential functions.
• Knowledge of manufacturing protocols, statistical tools and methodology, and continuous improvement techniques.
• Ability to be extremely detail oriented while working with high volumes of records
• Intense focus on providing support to internal and external customers in a timely manner.
• Work in conjunction with manufacturing, engineering and other functional groups on regulatory compliance issues.
• Interfaces with staff and external subject matter experts to resolve technical issues
• Understanding of and adherence to GMP practices and FDA regulations and ability to implement FDA or regulatory requirements as necessary.
• Knowledge of EU MDR, FDA, ISO regulations preferred.