My client is a successful medium-sized family-values manufacturer of Class II and III Medical Devices based in the Hamburg Area. They are looking for a Quality minded individual who wants to progress with them.
Minimum 3 years in a quality engineering role in Medical Device or Pharma industry.
Exposure of ISO 13485, ISO 14971, MDD and USFDA QSR Part 820
Build and maintain effective cross-functional relationships with internal departments such as Operations/Manufacturing, R&D/Engineering, Quality Control, and Regulatory Affairs to ensure following topics
- Support on new product development and design change project to ensure compliance to internal procedure and regulatory needs.
- Provide trainings to R&D team on regulations applied to new product development and any design change.
- Ensure that customer requirements are incorporated into product functional specifications and lead risk and failure analysis (FMEA) to ensure functional specification requirements are fully met during process/design validation.
- Participate in all design reviews to provide input on regulatory and organization’s needs.
- Responsible for verifying Design transfer activities to ensure compliance to internal procedure and regulatory needs.
- Develop quality assurance specifications, test methods, sampling plans and related written procedures.
- Provide quality guidance and participation in conducting risk management activities including, risk identification, risk analysis, FMEA, and risk mitigation.
- Work with R&D team to finalize DFMEA and with Process Engineering to finalize PFMEA.
- Provide input to R&D, Process Engineering for updating FMEA.
- Update processes, based on risk based approach.
Qualification / Verification / Validation
- Provide quality guidance and participation in Validation, Qualification activities including, review of protocol, identification of sample size, test method and reports.
- Support Process Engineering on process validation activities and Equipment qualification activities.
- Review and approve validation master plan
Post Market surveillance
- Responsible for effectively implementation and maintaining of Complaint process.
- Guide compliant coordinator for effective maintenance of complaint process.
- Provide inputs on investigation, Root cause analysis and identification of Corrective or preventive action on received complaints.
- Responsible for identifying notifiable complaint and handle as per organization and regulatory needs.
- Responsible for analyzing customer feedback data and identify action wherever needed with customer service team.
- Review and analyze production / manufacturing data to determine the primary factors affecting product quality, yield, complaints etc and drive continuous improvement initiative with both internal and external operations as necessary. Include both product and process
- Responsible for creating PSUR (Periodic Safety Update Report)
- Provide inputs to R&D and Process Engineering for risk file update
- Monthly and Quarterly Reporting to reporting manager.
- Responsible for team management which includes but not limited to training of team member, support team member, their performance evaluation, problem solving etc.
- Maintenance and development of the organization's Quality Management Systems in accordance with current applicable regulatory requirements as stated in Quality Manual.
- Support internal and external audit activities from various regulators, customers, and consultant as necessary.
- Apply the use of Quality Engineering methodologies, tools, statistical techniques, etc. to assist in the resolution of day-to-day quality issues.
- Prior quality engineering experience in the medical device
- Excellent verbal and written communication skills, teamwork skills, attention to detail and results orientation required
- Effective troubleshooting and problem solving skills.
- Ability to work both independently and in conjunction with a team.
- Knowledge of Quality System Standards/Regulations (ISO 13485, 21CFR Part 820, MDD93/42/EEC, ISO 14971, WHO GMP etc).
- Experience in the use of statistical tools (SPC, Six Sigma, MiniTab etc.)