Quality Assurance (QA Engineer with Medical Devices background)
Location: Lake Forest, CA(Day one onsite)
Experience. Required: 5+ Years
The Associate II, Quality Assurance Engineering, is primarily responsible for developing and maintaining quality evaluation and control systems, conducting inspections and tests, and performing root cause analysis to ensure reliability standards. You will apply advanced technical knowledge and problem-solving skills. Specifics include:
- Autonomously leads investigations into production and customer-facing quality issues of medium complexity to identify root cause, implement corrective and preventative actions, and monitor effectiveness.
- Demonstrates intermediate understanding and application of role-specific technical and Quality skills and serves as a Subject Matter Expert (SME) for a product line.
- Develops cross-functional relationships to successfully influence behavior within a team or project.
- Monitors and analyzes global product performance using a data-driven statistical analysis and risk-based approaches.
- Effectively communicates (written and verbal) complex technical problems and solutions to a variety of audiences within the organization.
- Ensures compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices. Supports internal/external audits.
JD 2 – Laser and Optician Technician
Pay rate: $35/hr. on C2C
Location: Lake Forest, CA
Experience. Required: 5+ Years
- Set up and align photonics laser systems according to technical specifications and blueprints.
- Adjust laser settings to ensure optimal performance and precision.
- Set up, load materials, and run a variety of manufacturing equipment to produce device components and/or sterile finished products, including equipment set-up and/or in-process adjustments to ensure appropriate settings and parameters to achieve product design and quality specifications.
- Perform inspections of machinery and output ensuring the processes are being completed in conformance with production specifications and maintain a stable and efficient process.
- Use tools and equipment to complete assembly, sophisticated testing tasks, and measurements of medical devices precisely following work order instructions and drawings. Perform quality assurance and reliability testing following established methods and procedures.
- Self-assess and troubleshoot work, which may include visual inspection under magnification, sequential review of own or colleagues' work, reworking assemblies as required to meet specifications, providing constructive team feedback, and calling out work issues and changes in equipment performance to supervisor for assessment and correction. Performs detailed review of paperwork (ex, Device History Record). Continuous Improvement: Identifies and supports Continuous Improvement. Analyzes performance and makes suitable recommendations. Participates in team projects that develop process improvement methods, solutions, and procedures to enhance product quality and/or improve manufacturing safety and effectiveness.
JD 3 – CNC Mill/Wire EDM Programmer / Setup / Machinist
Pay rate: $35/hr. on C2C
Location: Lake Forest, CA
Experience. Required: 5+ Years
As a Principal Technician/Sr. Specialist in the R&D Model Machine Shop in Lake Forest, CA, you will support Mechanical R&D builds for Ophthalmic Instrumentation development, complete machine setups on a wide variety of specialized and production equipment, generate first article/first piece product for inspection, and make required adjustments to equipment or programming to maintain compliance with quality standards.
In this role, typical activities will include:
- Supports Mechanical R&D builds for Ophthalmic Instrumentation development.
- Must be a Hands-on Machinist with Surfcam or Mastercam programming experience.
- 10-15 years’ experience on 5-axis prototype Okuma mills and Sodick Wire EDM Preferred.
- 10 years minimum with Surfcam or Mastercam including Surfacing
- Tolerance: Common +/-.002, Must be able to hold +/- .0005 when needed
- Balanced experience of programming, setup, and running machines
- Able to interpret blueprints accurately including tight tolerances (Full Knowledge of GD&T).
- Able to perform complete setups and First Piece Inspection with minimal supervision
- Complete machine setups on a wide variety of specialized and production equipment. Generate first article/first piece product for inspection.
- Make required adjustments to equipment or programming to maintain compliance with quality standards.
- Ability to read and interpret blueprints, sketches, drawings.
- Work directly with Engineers on Modifications on the fly when needed.
- First shifts.
- CNC Mill/Wire EDM Programmer / Setup / Machinist.
Thanks & Regards
Mohammad Faisal
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