We are seeking a dynamic Quality/Regulatory Engineer to join our growing Regulatory Affairs/Quality Assurance (RA/QA) Department. As the Quality/Regulatory Engineer you will support and contribute to the overall Quality Management System, apply the requirements to our processes, products or services, and ensure compliance to applicable laws, regulations and standards. You will actively participate in quality improvement endeavors while working collaboratively and cohesively with employees to resolve issues.
Under the supervision of Regulatory Affairs/Quality Assurance (RA/QA) Director, you will:
Ensure compliance of design, development, and testing by performing gap assessment against current relevant and applicable regulations and remediation of the Design History File for commercial product
Lead or participate in the development, implementation, compliance, and maintenance of standards (e.g., FDA, ISO 9001:2015, ISO 13485:2016, CE/UKCA/UL/SGS, etc.) and procedures
Support the manufacturing line to investigate and address quality issues
Monitor product and process performance metrics and act upon trends
Author, collaborate, and approve Quality System documentation including change orders, DHF, DMR, DHR, labels and labeling, etc.
Conduct internal, vendor, and process audits
Interface with suppliers to resolve quality issues
Assist in training personnel on all aspects of the Quality System and regulatory standards
Position Qualifications:
Bachelor’s Degree in Mechanical or Biomedical Engineering or related engineering or scientific discipline
Minimum five years of Quality Engineering experience preferably with technical knowledge and experience in the Quality Assurance and/or regulatory functions as well as the medical device industry
ISO 9001, ISO 13485 and cGMP (21 CFR 820) experience is a plus
Strong self-starter, effective team player
An effective oral and written communicator with the ability to lead meetings and clearly present ideas to employees and other stakeholders
Cellular Technology Limited (CTL), headquartered in Cleveland, Ohio, is a global biotechnology company with locations and distributors worldwide. We are the industry leader in the development, use, and manufacture of standardized immune monitoring tools used in clinical and research applications. We are committed to offering meaningful work, competitive salaries, a full-range of benefits, including comprehensive medical coverage, 401(k) with company match, generous paid vacation, paid holidays, life and disability insurance, dental and vision options, and the opportunity for professional development and career advancement. CTL is fully committed to Equal Employment Opportunity and world class diversity.
