Quality System Associate-Medical Device & Human-Cell-Tissue Product

Wixom, MI

We are seeking a Quality System Associate- Medical Device & Human-Cell-Tissue Products

We are an importer and distributor of drugs, including narcotics, prescription, ethical and OTC drugs, medical devices, cell-tissue-organs and natural health products in Canada. Also, we are an importer and distributor of medical devices, and human-cell-tissue products in the 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. We represent 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, the Quality System Associate-Specialist will review and prepare documentation and processes, communicate with vendors, and maintain all documentation and records.

Compensation: Open

Type: Full time on-site

Site activity: MDs, HCT/Ps

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).
• Perform or participate in site-related special projects.
• Perform other duties related to Quality Assurance activities as required.

Requirements

• Bachelor’s degree in Life Sciences (Biological Science, or Medical Technology are preferred)
• 3+ years of experience in MD and/or HCTP in an associate or above role
• Skilled at writing QMS technical documents
• Experience with regulatory of MDs and HCTPs
• Strong knowledge of US FDA MD and HCTP regulations.
• Strong knowledge, education and /or professional experience in regulatory requirements for Quality Systems and /or Regulatory Affairs
• 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

This is a full-time position with hours of 8:30 am – 5:00 pm Monday to Friday. Flexible hours may be required.