International Diagnostics Corporation with 40+ years of successful Research, Development and Manufacturing of Immunoassay Diagnostic Test Kits is looking to identify and hire a Manager of Quality Systems on a direct hire basis.
The Manager of Quality Systems will be responsible for, but not limited to:
- Ensuring compliance to all regulations referred to in Quality Manual.
- 510K Filings.
- Registering all products before they are sold.
- Completing declaration and safety / efficiency of products.
- International Regulatory Filings:
- Technical Files-CE
- Canadian Device License
- Other filings as required
- Responsible for Device Listings with FDA.
- Registering with FDA, State & Federal Inspections.
- Certification and surveillance audits from notified body for ISO/CE.
- Interfacing with inspectors.
- Interacting with environmental regulators & OSHA.
- Notifying President of changing regulatory requirements.
- Interfacing new programs to meet requirements for worldwide quality standards/ ISO.
- Interfacing with Directors of Manufacturing and Marketing.
- Managing Internal Audit Program.
- Completing reports.
- Acting as Chairperson to discuss audits, reports, corrections needed, and final determinations.
- Reviewing Quality Procedures to sign off on their authenticity and status.
- Managing Document Control System.
- Managing Training Program.
- Implementing changes needed to achieve compliance to ISO standards.
- Minimum Bachelor’s degree in science related field.
- 3-5 years’ experience in a quality management level role, working within a medical device or IVD manufacturing industry.
- Experienced in leading regulatory audits.
- Experience in Quality Systems, ISO 13485 and FDA Requirements.
- Experience with CAPA programs, deviation reporting, and document control.
- Excellent written and verbal communications skills.
- Basic computer skills (Word, Excel).
- Ability to think strategically.