Biotech- Quality Manager-ISO 13485/ 9001 immunoassays

Quality Manager

My client is a Biotech company that creates tools and reagents to power client’s rapid lateral flow immunoassays and develops and manufactures custom rapid assays for the office in Maryland (between Washington, DC and Baltimore).

They are hiring a QA/QC Manager, would manage efforts to ensure high, consistent quality across the organization. You would manage all aspects of quality, from planning and implementing to problem-solving. You will also play major roles as new products are being developed.

You must enjoy wearing multiple “hats” and handling all sorts of challenges (no two days will be the same, guaranteed). You must be a problem solver and dogged implementer.

Job responsibilities:

· Implements and ensures adherence to our ISO 13485:2016 quality system. Develops and/or reviews standards, policies, and procedures for all functions and departments involved with or related to the Quality System.

· Responsible for managing Quality Assurance and Quality Control functions and working with other departments to deliver high quality results on schedule. The QA/QC Manager makes decisions over the release of products and accepts the responsibility for compliance with relevant regulatory and company standards.

· Develops, documents, troubleshoots, and performs internal Quality Control processes used to evaluate materials in-process and finished products.

· Schedules and/or performs quality audits and reports findings to senior management.

· Receives, reviews, and troubleshoots quality issues and concerns. Reviews trends and analyses product/component failures. Initiates, Reviews, and Follows up on corrective actions with appropriate entities or personnel.

· Prepares presentations, reports and other documentation required or requested to support the Quality System.

· Assumes quality role on development or process improvement projects. Prepares validation, verification, and quality control plans. May action plans as requested.

· Involved in the education of our customers with regards to our Quality System and Quality Guidelines.

Requirements – our minimum requirements for the position.

· At least 3 years of experience in quality control/quality control management in a regulated (ISO, FDA, USDA, CE, etc.) environment

· Understanding of quality standards and ISO 13485/9001 methods and procedures

· Outstanding communication ability (oral and written)

· Comfortable performing laboratory tests, previous experience with Lateral Flow Assays is a plus.

· Proficient in MS Office software

· Bachelor’s degree in chemical, physical or biological sciences

For immediate consideration- send your resume