PTCA Balloon Process-Assistant Manager
22 hours ago
Job Description:
- Production & Process Management
- Supervise day-to-day manufacturing of PTCA balloons as per defined SOPs.
- Monitor critical process parameters such as extrusion, balloon forming, pleating, folding, bonding, and assembly.
- Ensure production output meets planned schedules, quality standards, and yield targets.
- Identify and troubleshoot process deviations, implement corrective and preventive actions (CAPA).
- Quality & Compliance
- Ensure strict adherence to ISO 13485, FDA 21 CFR Part 820, GMP, and internal QMS requirements.
- Collaborate with QA/RA teams during audits, inspections, and validations.
- Maintain accurate documentation of BMR, process records, and change control activities.
- Process Improvement & Validation
- Lead process optimization, yield improvement, and cost reduction projects.
- Prepare and execute process validation (IQ, OQ, PQ) protocols.
- Support technology transfer and scale-up activities for new balloon designs.
- People & Training
- Supervise and train operators/engineers in critical manufacturing processes.
- Monitor skill matrix and ensure cross-training to reduce dependency.
- Foster a culture of safety, discipline, and continuous improvement on the shop floor.
- Cross-functional Collaboration
- Work closely with R&D for product development and pilot builds.
- Support Supply Chain & Planning teams in material availability and production planning.
- Collaborate with Maintenance for equipment upkeep and calibration.
Key Skills & Competencies
- Strong knowledge of PTCA balloon manufacturing processes: extrusion, blow molding, balloon forming, folding/pleating, and assembly.
- Familiarity with polymers and materials used in balloon catheters (e.g., Nylon, Pebax, PET).
- Good understanding of cleanroom operations (ISO Class 7/8).
- Knowledge of statistical process control (SPC), Lean, Six Sigma, and problem-solving tools (8D, RCA).
- Strong leadership, team management, and communication skills.
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