Quality Management Systems Supervisor
Job ID: 2019-14790
Type: Regular Full-Time
# of Openings: 1
Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients’ lives.
This position is responsible for implementing, maintaining and improving the Quality Management System for all Aesculap US sites. Specifically review and revise, as needed, QMS policies and procedures to ensure the work conducted conforms to established corporate standards and industry regulations/standards. This includes the maintenance of the AIC/AIS Quality Systems (Change Control, Documentation and Training Systems). Implements and maintains the Electronic Record Management System as well as Electronic Training System requirements and audit readiness. This position is responsible for the change control systems, training, and documentation release activities that support product safety and quality and therefore has a direct impact on patient safety.
Responsibilities: Essential Duties
- Create and revise standard operating procedures, perform gap analysis against regulations, including updates to SOP and employee training. Ensuring the QMS is operating effectively.
- Create, update and/or manage Quality Metrics.
- Compile Management Review meeting slide and ensure preparation.
- Function as the site key compliance contact.
- Create/revise internal audit schedules with input of Director of Quality.
- Support all external regulatory audits.
- Conduct Internal Audits including leadership, coaching new auditors and SME (Subject Matter Experts), on site management, conflict resolution, conducting meetings, interviewing auditees, documenting audit observations, and reporting audit outcome to management.
- Acts as the lead and mentor for the personnel within the QMS group.
- Coaches new hires on the Change Control Notification, NCR, CAPA, and Deviation systems.
- Track and monitor effectiveness of document/change control process and develop/ implement programs designed to increase company employee knowledge of compliance policies.
- Works with AIC/AIS departments to provide instruction and enforcement of GMP compliance.
- Provide quality leadership and project management on the creation of electronic systems and workflows to support the QMS (i.e., Bdocs, Change Control).
- SAP Quality Management Super user.
- Capable of applying and leading teams in the use of Quality Tools, such as FMEA, in design, development, improvement and investigative activities.
- Develops Quality System document templates including SOPs, work instructions, validations, etc. in compliance to applicable laws and standards.
- Ensures SOPs, validations, and other documents are reviewed for consistency and compliance with relevant federal and state regulations.
- Ensure the QMS is operating effectively. Create, update and/or manage Quality Metrics.
- Assists in the development, presentation and recording of training as needed.
- Prepares materials for and leads Management Review activities.
- Maintains Quality Dashboard metrics for input into Management Reviews.
- Must comply with applicable ISO and FDA regulations as stated in AIC Quality Manual.
- Must embody the Company’s Vision, Mission and Values.
- Other duties may be assigned.
Secondary or peripheral job functions:
- Organizes and maintains standards (ISO/ASTM/AAMI, etc) for reference.
- Organizes and maintains the library of publications and provides notifications of updates.
- Ensures monitoring of the Training System for On-time Compliance.
- Assists Departmental managers and Training with Curriculum assignment per Job Description.
- Coaches and Trains new hires on Quality System.
- Ability to work extended hours, including evenings and weekends.
- Excellent interpersonal skills required.
- Quick learner with good analytical skills.
- Ability to work independently.
- Contribute to creating a climate of trust, ethics, and accountability by effectively seeking out and accepting feedback from others.
- Possess the ability to exceed expectations with the customer in mind and take responsibility for driving key results as well as empower others to achieve desired outcomes.
- Demonstrate behaviors that drive efficiency by understanding and improving processes as well as sharing best practices.
- Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws.
- Responsibilities include interviewing, hiring, and training / development of employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Act as a lead team member in all aspects of GMP quality operations.
Expertise: Knowledge & Skills
- Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
- Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
- Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- B.S./B.A. degree with 6-8 years of Quality System experience in Medical Device, Pharmaceutical, Biotech or other regulated industry.
- Thorough knowledge of and ability to interpret the cGMPs and state regulatory requirements is essential.
- QA Supervisory experience is required.
- Requires good working knowledge and experience working with GMP Quality Systems.
- Must have the ability to process, analyze and present data.
- SAP Quality Management experience preferred.
- Knowledge of basic statistical analysis is required.
- Computer skills in MS Office; Excel, Word, and Visio.
- Excellent oral and written communication skills required.
- Must have strong organizational skills.
- Must be detail oriented.
- Experience with electronic systems and workflows to support the QMS (i.e. Bdocs, Change Control, SAP QM) is a plus.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.
Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
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