Main Purpose of Role
The Lead- Quality control is a staff level lead position with responsibility to work with high attention to detail on inspection of production parts and assemblies. This position will be responsible for determining and executing inspection plans according to engineering drawings and specifications, maintain documentation, calibrate measurement instruments, maintain the Capital equipment and instruments, and collaborate with suppliers/operations and engineers to maintain quality of product, inspect parts before accepting those in inventory, maintain quality manual, maintain and update inspection procedures.
- Define inspection plans with the help from engineers.
- Execute inspection plans for all production parts.
- Maintain all instruments used in inspection well organized and in working conditions at all the times.
- Calibrate all inspection tools in-house with help from professional services (as needed) for certain instruments to maintain them current.
- Define inspection plan for tooling owned at various manufacturing partners and suppliers.
- Provide feedback to operations and engineering when inspection indicates tooling at manufacturing partner needs rework/replacement.
- Conduct visual inspection, as well as assisted inspection on parts as defined in the procedure and requirement.
- Lead MRB meetings, to ensure deviations are being addressed in timely manner.
- Identify capital requirements for purchasing new equipment/techniques for improving accuracy of measurements.
- Support other Asepco personnel, technicians to meet project milestones.
- Continuously improve the processes and their efficiency to meet production demands.
- Participate in tooling inspection, vendor audits as necessary.
- Participate in inspection of parts at vendor’s location as necessary.
- Identify trends in manufacturing deviations and provide feedback to engineering and operations team.
- Implement procedures related to quality control and inspection of parts and assemblies, and intracompany transactions.
- Create deviation requests and ensure they are addressed with documentation.
- Schedule inspections for components manufactured on volume scale.
- Support new product development projects with quality control function.
- Maintain all the inspection documents, logs related to manufactured components.
- Maintain calibration record of all the callipers, micro-meters, gauges, instruments and measurement tools.
- Maintain all procedures related to Quality inspection and Quality control.
- Inspect and maintain all MTRs and certifications per standard procedures.
- Maintain department KPI related to on-time inspection, supplier deviations.
- Maintain quality manual current with the design and industry specifications.
- Maintains training records of quality control technicians and inspectors.
- Record and maintain information related to inspection in MRP software as defined by internal procedures.
Certifications and training
- Maintain examiner certification according to industry standards and requirements.
- Suggest and organize suitable training for QC personnel to ensure they are up to date with the industry standard knowledge.
- Train and mentor quality inspection team for required compliance and measurements.
- This position has currently one direct reports and may have more than one direct reports in future
- Bachelor’s degree in Mechanical Engineering, Master’s degree is a plus.
- 3+ years’ Quality Control/Quality Assurance experience required.
- In-depth knowledge of measurement techniques and instruments.
- 3+ years’ experience related to various manufacturing techniques and practices.
- 2+ years’ experience of working with local and global vendors.
- Ability to interpret standards, engineering drawings and specifications.
- Knowledge of basic metallurgy.
- Strong communication and organizational skills with ability to work on multiple priorities at once with high attention to detail.
- Proven experience in implementing processes in collaboration with cross functional teams.
- Familiarity with statistical quality control.
- Strong interpersonal skills.
- Fluent written and verbal communication in English is required.
- Strong analytical and technical writing skills.
- Knowledge of relevant industry standards (ASME BPE, USP VI, FDA, PED (EU), cGMP, BPOG) is a significant plus.
- Familiarity with rubber molding technology, injection molding, compression molding, plastic manufacturing.
- Experience with process components used in Biopharmaceutical Industry.
- Familiarity with cleanroom manufacturing practices.
- Knowledge of Welding, fabrication and inspection methods as well as ASME BPVC/AWS code is plus.
Working conditions are in an office and warehouse/assembly environment with regular use of measurement instruments phone and computer, for email and communication media.
Able to lift up to 50 lb occaisionaly.
Candidate must be able to travel on occasion to assess and visit vendors and other Watson-Marlow group companies as required.