Manager, Quality Assurance

MESO SCALE DIAGNOSTICS, LLC.•Rockville, MD

7d•$116,600 - $177,800•Hybrid

About The Position

This position is responsible for developing, implementing and maintaining quality systems and compliance programs that adhere to corporate policies and the company’s active regulatory certifications. This position manages activities that include internal audits, supplier quality, corrective and preventive actions (CAPA), complaints, and field actions.

Requirements

Bachelor’s Degree in Biology, Chemistry, Biochemistry (or other Life Sciences) or Engineering is required.
Minimum of eight years of experience in supplier quality and internal auditing in an ISO or FDA QSR environment.
Experience working with FDA and/or ISO auditors is required.
Two years of management experience required.
Strong knowledge of ISO 13485 and ISO 9001 required.
Track record of successful maintenance of an internal audit program and supplier quality program.
Strong audit fundamentals and analytical background.
Strong logical problem-solving skills and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion.
Leadership skills with demonstrated knowledge and understanding of staff management practices and processes and the ability to establish accountabilities and expectations and manage performance to achieve results.
Strong business acumen, negotiation and mediation skills, as well as a demonstrated attention to detail and a focus on achieving quality outcomes.
Ability to build/foster relationships.
Excellent oral, written communication and interpersonal skills.
Able to effectively communicate issues/problems and results that impact timelines, accuracy and reliability of audit data.
Proficiency in MS Office Suite.
A wide degree of creativity and latitude is expected including the ability to multi-task and work productively in a demanding production environment with changing priorities.

Nice To Haves

ASQ certification (CQE, CRE, CQA) is strongly preferred.

Responsibilities

Maintain and continuously improve our quality management system and ensure that processes remain in compliance with company policies and other regulatory requirements as applicable.
Implement and maintain tools for monitoring the health and effectiveness of the quality management system.
Lead initiatives to determine quality system best practices and determine which current processes require improvements/updates.
Manage department activities as well as lead all MSD activities related to internal audits, supplier quality, customer audits, CAPA, complaints and field actions.
Establish and monitor staff performance and development goals, assigns accountabilities, sets objectives, establish priorities, and provide continuous feedback and recognition on performance.
Promote a culture of high performance and continuous improvement that values learning and a commitment to quality.
Develop, revise and implement departmental Standard Operating Procedures (SOPs).
Ensure timely execution of the internal audit schedule.
Monitor CAPA activities and establish/maintain program to follow up on corrective action responses.
Implement appropriate problem resolution methods and verification of effectiveness.
Oversee Quality review of customer complaints and ensure that the problems are addressed in a timely fashion.
Establish and execute a supplier audit schedule. Evaluate new suppliers based on their ability to provide processes or products and services in accordance with company’s requirements.
Evaluate, monitor and remedy product quality and quality system concerns associated with existing suppliers.
Establish and execute a supplier audit schedule Participate in customer and other external audits.
Specific duties may vary depending upon departmental requirements.