Senior Director, Quality
Mesa Biotech is a fast growing, ISO certified, FDA approved, medical device company that has achieved a dramatic simplification in the complexity of DNA and RNA molecular testing. Our patented technology provides everything needed to conduct rapid molecular tests at the point-of-care. The palm-sized, reusable dock and disposable test cassette form a user-friendly system for use anywhere, from the physician’s office to the patient’s home.
We are seeking a Senior Director, Quality who will be responsible for providing direction and supporting the R&D design control process, process development, process validation, test method validation and manufacturing with an emphasis on product quality.
You will work closely with Management to develop quality requirements as defined by the strategy and overall direction of the company; executes plans to ensure company meets its stated objectives. The Senior Director, Quality performs a variety of duties that involves engineering analysis and problem solving as well as developing quality systems protocol and processes. This role will also participate in audit preparation and execution. Advocate compliance to FDA and ISO 13485.
We are looking for someone with:
- Strong knowledge of the FDA QSR’s as well as the point-of-care, in-vitro diagnostic. Knowledge of other country directives and regulations is highly preferred
- Prior experience in the Medical Device and/or IVD industry with early stage (Start–up) company experience highly preferred
- Experience in leading FDA and Notified Body Audits
- Design control experience with 510k and PMA products
- Must possess excellent written and verbal communication skills
- Working knowledge of inspection tools such as: calipers, micrometers, snap gage, microscope, tensile tester, VIS and pin gages.
- Product testing experience
- Experience with medical device and/or IVD manufacturing processes qualifications (IQ/OQ/PQ)
- Experience with medical device and/or IVD design controls
- Intermediate level skill in Microsoft Word, Excel, Outlook and other office software programs
- Knowledge of Solidworks is a plus
Your responsibilities will include:
- Identify and implement QA process improvements
- Manage the Master Validation Plan
- Review and provide guidance on how to create, execute and complete validation and qualification (IQ/OQ/PQ) documents
- QA review and release of all production documents
- Perform supplier audits
- Disposition of non-conforming material
- Product returns and complaints
- Perform internal audits and recommended improvements to ensure compliance with the ISO 13485, FDA, QSR and MDD standards
- CAPA System and root cause investigation
- Provide and ensure quality standards meet device packaging requirements
- Ability to establish, build and maintain professional working relationships with all levels of staff, clients and suppliers
- Complete the development of the quality system documents and processes for ISO 13485 and FDA compliance
- Risk management process and leading root cause investigations
- Quality representative for project improvements and eliminate quality problems
- Report quality metrics for Quality Management Review
- Support Product and Process Development process for new products, product changes and enhancements
- Support manufacturing operations and supplier quality management
- Develop new test methods and perform test method validation in compliance with FDA and ISO requirements
- Provide quality support to engineering and manufacturing for troubleshooting and resolving technical problems
- Coordinate work and ensure quality deadlines are met between outside vendors and internal personnel
- Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions
- GMP compliance in coordination with the Document Control, R&D, and manufacturing functions
- Complete accurate and timely review of manufacturing documentation including manufacturing records, inspection records, materials records, etc.
- Compliance with established Company and departmental policies and procedures, objectives, quality assurance program, safety and environmental standards
- Other duties as assigned; as emerging growth company it may be required from time to time to assist in other areas other than the area of specialty
We are looking for someone who has experience in:
- Commercialization of at least two point-of-care, in-vitro diagnostic platforms
- Experience with the development of point-of-care, in-vitro diagnostic platforms that address ISO 13485 design control requirements
- Experience with managing the quality system processes (NCRs, CAPAs and Deviations)
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
- Ensure that all regulatory and internal policies are followed
- Makes good decisions in a timely manner, based upon a mixture of analysis, wisdom, experience and judgment
- Resolves issues and overcomes obstacles to assure successful events; uses independent judgment to resolve unique challenges that arise with each event
- Orchestrates multiple activities at once to accomplish a goal; uses resources effectively and efficiently; is able to adjust changes in priorities
- Is dedicated to meeting expectations and requirements of internal and external customers
- Excellent interpersonal, verbal and written communication skills Meticulous attention to detail and meeting deadlines
- Demonstrates accuracy and thoroughness and monitors own work to ensure quality
- Self-starter with can-do attitude to strive quality excellence in a fast paste start up environment
At Mesa Biotech, we offer a competitive salary, comprehensive benefits including: medical, dental, vision, flex plan, life/disability insurance, 10-paid holidays, 15-days PTO and a 401(k) plan.
If you like the start-up environment, have a problem driven mindset, want autonomy working for an innovative company; get ready to roll-up your sleeves and join our team of collaborative people!