The Quality Assurance Manager is responsible for providing leadership in establishing, implementing and maintaining quality system processes and documentation in compliance with relevant regulatory requirements.
The Quality Assurance Manager is required to perform training per their individual training plan. The Quality Assurance Manager is responsible for:
1.1 Ensuring compliance of operations including the QMS with ISO/IEC 17025.
1.2 Establishing, implementing, communicating, and maintaining the Quality Policy, Quality Objectives and the Quality Management System.
1.3 Ensuring the processes for the QMS are followed at all times.
1.4 Fulfilling the role of Management Quality Representative and schedule and complete timely management review presentations to report the performance of the QMS to top management with appropriate quality data analysis and any need for improvement.
1.5 Establishing strategic plans, policies, and procedures to ensure the Quality Systems program will meet or exceed internal and external customer needs and expectations.
1.6 Participating in regulatory inspection activities with regulatory agencies.
1.7 Ensuring deputies are appointed for key managerial positions as needed.
1.8 Providing and maintaining a system to evaluate suppliers and service providers.
1.9 Providing assistance to the investigation and resolution of customer complaints when required.
1.10 Maintaining the Quality Management System (QMS) through regular review, internal audits, management review, and corrective and preventive action.
1.11 Assisting other functional areas by providing review and approval of quality related documents.
1.12 Managing document control activities for document systems that include procedures, associated work instructions, forms and the quality manual.
1.13 Maintaining a system for employee training.
1.14 Facilitating day-to-day Quality operations including but not limited to; Document Control, Employee Training, Purchasing and Shipping/Receiving, Work Order Program, GLP Auditing, Corrective and Preventive Actions, Controlled Equipment Management, Facility Maintenance, Internal Audits, Supplier Quality, and Record and Data control.
1.15 Training quality staff in operation and maintenance of the quality management system.
1.16 Appointing deputies for key managerial personnel.
1.17 Ensuring that for any given study, the QA unit is entirely separate from and independent of the personnel engaged in the direction and conduct of that study.
1.18 Reviewing and/or training quality staff to review study reports to assure that each report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the laboratory study. Also ensure no deviations from approved protocols or standard operating procedures are made without proper authorization and documentation.
1.19 Ensuring the promotion of awareness of customer and other relevant requirements throughout the organization.
1.20 Ensuring all employees are provided with a work environment free from harassment of any kind.
1.21 Setting good examples for others and serve as a role model.
The Quality Assurance Manager is required to possess the following education, experience, and skills:
1.1 Minimum of a Bachelor’s Degree in a scientific or engineering field.
1.2 Minimum of 6 years of experience in Quality Systems or related area.
1.3 Ability to effectively drive project schedule and objectives from project initiation to completion.
1.4 Supervisory experience and proven ability to effectively motivate, manage and develop personnel.
1.5 Excellent understanding of quality system requirements including ISO/IEC 17025 and 21 CFR part 58. Experience in ISO 9001, 21 CFR Part 820 and Part 11, ISO 13485, and other relevant international standards highly desirable.
1.6 Must be organized, with excellent analytical and problem-solving abilities, strong verbal and writing skills and good interpersonal and leadership skills.
1.7 Proficiency with a Windows environment.
Preference is given to local candidates
About BDC Laboratories
Biomedical Device Consultants & Laboratories (BDC Laboratories) is a fast-growing company that offers comprehensive ISO 17025 accredited medical device testing services, design verification test equipment, and silicone mock vessels & anatomical models to the medical device community in support of domestic and international regulatory submissions and approvals. Our primary focus is cardiovascular technologies such as endovascular stents, prosthetic heart valves, and catheters. BDC's environment is fast-paced, dynamic, challenging, and rewarding