Innova Medical Group, Inc. achieves to deliver better global health outcomes with its deep expertise in testing and unique offerings in diagnostic medical devices and services that help tackle some of the world’s most challenging healthcare problems. Alongside of COVID-19 solutions, Innova specializes in innovative screening, testing and diagnostics for cancer, heart disease, arterial calcification, stroke, and virus detection focused on infectious disease.

This person will be working at the MPS facility located in Brea, CA. MPS was acquired by Innova Medical Group at the end of 2020.

The Quality Control Manager plans, manages, and controls programs and procedures that maintain an acceptable level of product quality as established by various federal, state, customer, and company requirements, including quality of purchased material, in-process material, and finished goods.

Responsibilities

• Provides leadership and guidance in implementing action for quality control programs
• Ensures that processes needed for quality control are established, implemented, and maintained
• In conjunction with Director of Quality, reviews and approves manufacturing and assembly instructions for adequate point of inspection operations; determines appropriate documentation for inspection points
• Assist with development of finished product and component receiving inspection procedures and requirements
• Support, coordinate and oversee site customer-requested, external regulatory, and internal audit.
• Provides oversight and ensure compliance of QS support elements for the site QMS; Internal audits, Training, Document Control, Supplier Quality Management, Complaint Management, CAPA, NC Management, and Calibration Systems
• Supervises and/or conducts quality control reviews at established inspection points. Verifies and maintains quality control records
• Maintains higher level quality system documents including Quality System Manual (QSM), Work Instructions (WI), Standard Operating Procedures (SOP) related to Quality
• Participates in the review of all design, manufacturing, purchasing, and test documentation to assure conformance to quality control standards. This can include review of drawing, specifications sheets, production procedures testing and inspection standards, vendor inspections and customer contract specifications
• Makes recommendations regarding facilities, equipment, personnel, procedures and systems to carry out quality control function
• Responsibility for product quality issues (i.e., inspection, test and measurement, nonconforming product, etc.)
• Supports Material review board (MRB) activities for nonconforming product
• Responsibility for site Corrective and Preventive Action (CAPA) system, site specific complaint investigations, site specific training program, documentation control system, and quality control records
• Supports validation activities and approvals, as needed
• Provides quality training for personnel as needed
• Maintains Quality Agreements (as required) with customers

• 4- year degree in manufacturing or industrial engineering, quality assurance, regulatory affairs, science, or related field
• 5+ years of experience in Quality Assurance and/or Regulatory Affairs
• Auditor certificate or equivalent experience
• 3 years supervisory experience
• Competent knowledge of equipment and manufacturing operations
• Thorough understanding of Validations (including equipment qualification (IQ/OQ), process validation, test method validation, computer systems and software validations, etc.); understanding of process capability
• Thorough understanding of medical device quality system standards, specifications, laws, and regulations, i.e., FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and other industrial standards as applicable
• Knowledge of product drawings, specifications as well as measuring and testing devices

All your information will be kept confidential according to EEO guidelines.

Legal authorization to work in the United States is required.

This job may be subject to a background check, consistent with State and local law, including where applicable the Los Angeles Fair Chance Ordinance, San Francisco Fair Chance Ordinance, and the California Fair Chance Act.