Principal Responsibilities
· Supports company goals and objectives, policies, and procedures in compliance with the quality management system, FDA, EU, Canadian, Brazil and Japan International regulation/requirements
· Develop, execute, and maintain technical documentation such as 510(k)’s, design history files (DHF’s), device history and master records (DHR’s/DMR’s), IQ/OQ/PQ plans and protocols associated with product/process quality according to but not limited to FDA, EU, Canadian, Brazil and Japan regulations and company specific SOP’s
· Write up, review and revise qualification measurement system analysis (MSA's), Standard Operating Procedures (SOP's), Statistical Process Control (SPC's) and Failure Modes and Effects Analysis (FMEA)
· Provides quality engineering support to manufacturing and product development groups. Works closely with Operations and Engineering to develop and implement appropriate risk management, qualification, verification/validation plans
· Assesses and provides recommendations for improvement of processes and equipment for compliance to cGMP and current ISO 13485 regulations within the Manufacturing, Quality & Regulatory processes to ensure safe and effective products are produced
· Provides written reports and supporting documentation for recommendations
· Reviews ECR’s to ensure compliance to Quality Management System, FDA, EU, Canadian, Brazil, Japan and other International requirements (as needed) for new and current products
· Supports the CAPA process, collaborating with owners to ensure effective root cause analysis and the development of innovative, long-term solutions
· Tracks effectiveness of corrective action plans and compliance improvement initiatives
· Ensures accurate project schedules are maintained and communicated to both internal and external management
· Maintain Internal Audit and Calibration programs per FDA Part 820 and ISO 13485 standards
· Responsible for performing and reporting on Supplier/Vendor Quality Audits
· Responsible for final product QC inspection and product release
· Carry out other reasonable tasks as required by the Chief Operating Officer
Job Type: Full-time
Pay: Up to $75,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
Application Question(s):
- Do you hold a Bachelor / Masters of Science (BS/MS) degree in Biomedical or Mechanical Engineering (other science based technical degrees will be considered) with a minimum of 6 years of Quality/Regulatory experience in the medical/pharmaceutical industry ?
- do you have strong technical writing skills and ability to create technical protocols and reports as well as manufacturing inspection procedures ?
- Have you got a thorough understanding of Current Good Manufacturing Practices, Quality Systems, Regulatory requirements, Validation Principles and Manufacturing Methods in a medical device / pharmaceutical regulated environment (demonstrated knowledge application of quality saystem regulations- 21CFR820, MDR 2017/745, MDD regulations, ISO 13485 , ISO 14971 and other international standards) ?
Experience:
- medical device company or equivalent: 6 years (Required)
- MDR / MDD regulations: 6 years (Required)
Work Location: In person
