Quality Systems Manager

  • Full-time

Company Description

On December 31st, 2020 Innova Medical, Inc. acquired MPS Medical to expand its U.S production of COVID-19 antigen test kits, producing over 4 million SARS-CoV-2 Antigen Rapid Qualitative Tests per day.  Currently, Innova Medical Group, Inc. is the world’s largest manufacturer of rapid antigen test kits and leader in COVID-19 testing solutions arena.

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.

In this role you will report on the performance of the Quality system (QS) for Management Review meetings and any need for improvement; prepares agenda and establishes records for Management Review meetings.

www.innovamedgroup.com

 

Job Description

· 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.

· Provides leadership and guidance in implementing action for quality programs and for controlling quality costs.

· Serves as Management Representative for the QS and represent the Company in all audits.

· Ensures that processes needed for the QMS are established, implemented and maintained.

· Ensures the promotion of awareness of regulatory and customer requirements throughout the organization.

· Ensures establishment and maintenance of site regulatory registrations.

· Support, coordinate and oversee site customer-requested, external regulatory, and internal audits.

· 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

· Reviews and approves of all QS documents.

· Maintains higher level quality system documents including Quality System Manual (QSM), Work Instructions (WI), Standard Operating Procedures (SOP) related to Quality.

· Ensures that processes needed for the quality management system are established, implemented and maintained.

· Manages the internal audit program including planning, scheduling, review and approval of audits.

· Has responsibility for product quality issues (i.e., supplier evaluations and approvals, inspection, test and measurement, nonconforming product, etc.)

· Supports Material Review Board (MRB) activities for nonconforming product.

· Has responsibility for the Corrective and Preventive Action (CAPA) system, complaint handling system, training program, documentation control system, and quality records.

· Supports validation activities and approvals, as needed.

· Provides quality training for personnel as needed.

· Maintains Quality Agreements (as required) with customers.

Qualifications

· 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) and Current Good Manufacturing Practices (21 CFR Part 210 & 211), ISO 13485, and other industrial standards as applicable.

· Knowledge of product drawings, specifications as well as measuring and testing devices

Additional Information

PHYSICAL DEMANDS –Reasonable accommodations may be made to enable individuals with disabilities to perform the following essential physical demands:

  • Physically able to sit, stand and walk for extended periods of time.
  • Able to move about on foot; walk up and down stairs repeatedly as needed.
  • Clarity of vision at 20 inches or more; able to view a computer monitor for extended periods of time.