Quality System Associate-specialist position - Medical Device & Human-Cell-Tissue Product
#277443
Wixom, MI, US
Description
We are looking for a Quality System Associate-specialistposition - Medical Device & Human-Cell-Tissue Product
HANSAmed Ltd is importer and distributor of Drugs including Narcotics, Prescription, ethical and OTC drugs, Medical Devices (MD), Cell-Tissue-Organs (CTO) and Natural Health Products (NHP) in Canada. Citagenix Regen, LLC is importer and distributor of Medical Devices (MD), and Human-Cell-Tissue products (HCTP) in USA. We are committed to providing exceptional service and brand awareness to thousands of hospitals, dental and oral surgery clinics that we serve in Canada, the United States and around the world. HANSAmed represents leading brands in their respective categories.
The Quality System Associate-specialist position is primarily responsible for providing quality assurance for the Distribution Center including activities pertaining to site audits. In addition, Quality System Associate-specialist will review and prepare documentation and processes, communicate with vendors, and maintain all documentation and records.
Compensation:60,000.00
Type: Full time on-site.
Site activity: MDs, HCT/Ps
Company: Citagenix Regen, LLC
Location: Wixom, MI.
Key Responsibilities
60%
- Participate in quality inspection of incoming MD and HCT/P products, imported or domestic, documentation, and release to inventory.
- Review of SAP goods receipts for incoming product shipments.
- Conduct regular warehouse inspections, resolve any nonconformances to ensure inspection readiness.
- Adhere to company policies, procedures, and standards while performing job duties.
- Maintain the Quality Management Systems (QMS), documentation records, logs.
- Support and review the customer-related returns, records, and provide decisions on product disposition.
- Review, document and support the closure of any Change controls and Nonconformances.
- Support the registration and renewal of US state licenses for MD & HCT/P activities.
- Contribute to company process for Product Quality Complaints for products sent from the site.
- Support MD, HCT/P or other supplier onboarding, and re-qualification related activities.
- Review temperature data and maintain temperature logging equipment.
- Review and support any activities related to pest control program, resolve any nonconformances.
- Support documentation and resolution of inventory count discrepancies.
20%
- Review the US regulations changes to ensure MD and HCT/P SOPs meet regulatory requirements.
- Participate in risk assessments related to product, labelling, facility, equipment, process changes.
- Support submission of state-specific annual reports.
- Support with any new or existing staff training on QMS, GDP, etc.
- Support the renewal and maintenance of FDA establishment registrations for MD and HCTP products.
- Support MD Problem Reporting and HCTP adverse events reporting to FDA, and state authorities.
- Support the exporting activity, ensure products meet regulatory, licensing, and documentation requirements prior to export.
10%
- Participate in ISO audit, FDA audit and supplier audits for US market activity.
- Conduct and document an annual mock recall of MDs and HCTPs.
- Participate in annual self-inspection and corrective /preventive actions.
- Participate in any Field alert or market Recall for MDs and HCTPs in USA.
- Maintain the eSubmitter and FDA Electronic Submissions Gateway Next Generation (ESG NextGen).
10%
- Perform or participate in site-related special projects.
- Perform other duties related to Quality Assurance activities as required.
Requirements
Pre-Requisite for this position:
Technical (must meet at least one of the following):
-Bachelor’s degree in Biological Science, or Medical Technology; or
-Bachelor of Science degree in another discipline (acceptable disciplines include Microbiology, Chemistry, Pharmacology, Kinesiology, Biotechnology, Toxicology, or alike) and 5+ years of experience working in tissue bank with a Medical Director; skilled at writing QMS technical documents; proven experience on regulatory MDs and HCT/Ps; strong knowledge of US FDA MD regulations, and HCTP regulations; or
-Registered nurse in state of Michigan
Skills & Competencies
- Strong knowledge, through education and /or professional experience in regulatory requirements for Quality Systems and /or Regulatory Affairs
- Knowledge or hands-on experience in tissue bank operations, including processing, storage, and regulatory compliance
- Detail oriented and accountable for making accurate decisions under set guidelines
- SAP experience is an asset
- Excellent reading, writing, communication, math, and computer skills
- Ability to follow instructions, work under stress, and handle multiple assignments
- Strong problem-solving skills
Physical and work conditions
- Lift, carry or move products up to 50 lb., occasionally
- Walk on concrete floors continuously
- Handling various tools (Tape gun, Utility knife, Computer)
- May be exposed to dust, occasionally
- Work in a cold environment, occasionally
Do not applY IF
if you do not meet these technical requirements and /or if you are not comfortable with the physical and working conditions.