This position is unique as Baytech is developing the center of excellence for capital equipment manufacturing within BSC. This is a post integration opportunity that will drive product and process improvements.
The Director of Quality Assurance leads a team of QA Managers, Senior Engineers, Engineers, Technicians and other QA professionals to ensure full compliance to all GMP/QSR practices and standards as defined by the Food and Drug Administration, ISO and other regulatory bodies as they apply to capital equipment, installation, service and repair.
• The QA Director will provide leadership and direction to his/her team and ensure a Quality Management System exists to meet the various requirements of a medical device manufacturing facility. Specifically, he/she will ensure that the necessary monitoring of environmental controls, management of documentation process’s including storage, retention and review, establishment of internal auditing programs, verification of all products and process’s to the established quality standards through 100% testing or statistically valid sampling. Validation of new products/process’s or changes to existing products/process’s, establishment of a vendor review and rating systems are in place on Site.
• The QA Director will build a strong and sustaining relationship with Production, Service, Engineering, Corporate QA/Regulatory, external Regulatory bodies and others and will be recognized as an excellent team player within the total organization on site.
• He/she will be committed to developing people and is recognized as an expert in mentoring and coaching individual and team performance while visibly demonstrating the core values of BSC in his/her everyday leadership style.
• He/she will continuously foster and drive a continuous improvement approach to Quality on Site ensuring that quality is the responsibility of everyone - not just the QA department and that the Quality System is an integrated and integral aspect of the total running of the Site.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.
What we are looking for
Basic Qualifications
• Bachelors of Engineering, Science or technical degree and related development and design experience in the medical device with a minimum of 12 years in FDA regulated industry (or equivalent combination of experience and education)
• Minimum 10 years people management experience
• Ability to interact with senior leadership across the organization
• Must have demonstrated leadership, coaching, employee development, influencing, and negotiation skills
• Demonstrated presentation and facilitation skills required
• Proven history of driving process improvements. Process excellence experience and experience leading change management projects.
Preferred Qualifications
• Master’s Degree in Engineering/Science or MBA preferred
• Experience managing quality functions within medical capital equipment manufacturing and service
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