We are a medical device company that is a supplier of catheters and combining science, technology, and innovation to provide new solutions to medical professionals. Our new line of devices furthers our commitment to supplying new and unique solutions in connecting patients to critical life support devices.

Position summary

Insure all Quality Procedures, inspection and testing methodologies are followed in local facility while insuring vendor quality and environmental monitoring of clean rooms at both locations (locally and in Mexico).

This position is an active member of our Quality auditing team and Quality Representative for MRB and CCB and Master Control Plans.

This position is also the direct supervisor of Inspectors at the local facility while insuring gage R&R with Mexico facility.

Responsibilities:

• Follow all Quality System Requirements and SOP’s as defined by company polices insuring that FDA and Quality Standards are met.
• Quality Representative for Material Review Board (MRB) of components manufactured in the CA facility.
• Quality Representative for (CCB) of components manufactured in CA and Mexico.
• Owner of all inspection and test methodologies, and gage R&R including gage R&R between facilities.
• Lead internal auditor for both Mexico and CA facilities.
• Participate in external audits.
• Participate and approve specifications (input/outputs), verification and validation, risk management activities including DFMEA and PFMEA, Quality Plans and to assure products meet specifications.
• Provide Engineering studies as needed.
• Owner of Supplier Quality Assurance including; qualification, monitoring and management of SCAR’s.
• Project Manager for all Supplier related root-cause investigations and corrective actions.
• Owner of clean room environments including; qualification and monitoring for both CA and Mexico facilities.
• Owner of outsourced Sterilization activities including; qualification, monitoring and periodic revalidations.
• Develop and manage Quality metrics associated with areas of responsibility including inspection, MRB, suppliers, clean room monitoring and sterilization.
• Conduct engineering studies relating to Gage R&R, Cpk, SPC and Process Validations.
• Conduct root-cause analysis as assigned relating to customer complaint and product returns
• Provide technical quality support and documentation for pilot production, validation and verification built.
• Implement ongoing quality improvement processes working with cross functional teams.
• Supervise and Lead the Quality Inspection Team, with dotted-line to incoming inspection for Mexico.

Qualifications:

• Strong working knowledge of ISO 13485:2003, QSR, ISO 14971:207 and related standards
• A minimum of five years related experience in the medical device industry.
• A Bachelor's degree in engineering or related discipline is required (Microbiology is highly valued). A master's degree in engineering or related discipline is preferred and may substitute for some of the years of required experience.
• Well developed written and verbal communication skills in English and Spanish. Ability to write and comprehend instructions, short correspondence, and memos. Ability to effectively present information to senior managers and other employees of the organization.
• Ability to solve practical problems and deal with a variety of concrete variables and ability to interpret a variety of instructions furnished in written and oral form.
• Measurement devices (vision system, caliper, micrometers, and variety of gages).
• Experienced with Microsoft Windows, Outlook, Word, Excel, Microsoft Project, etc. is required.
• Generate reports using data analysis, SPC analysis/tools, etc. and effectively communicate findings/proposals to various users in the organization