Quality Assurance Manager

MESO SCALE DIAGNOSTICS, LLC.; Maryland; On-site; USD 117,000 - 178,000; Full time

Job summary

Meso Scale Diagnostics (MSD) is seeking a senior quality professional to develop and maintain our quality management system, ensuring compliance with ISO 13485 and FDA QSR. You will lead internal audits, supplier quality, CAPA, complaints and field actions, while driving process improvements and staff development.

The role requires eight years of supplier quality and internal audit experience, plus management skills and ASQ certification in preferred areas.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Biochemistry (or Engineering) is required.
• Minimum of eight years of 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.
• ASQ certification (CQE, CRE, CQA) strongly preferred.

Responsibilities

• Maintain and continually improve the quality management system in compliance with policies and regulatory requirements.
• Lead internal audits, supplier quality, CAPA, complaints and field actions.
• Monitor and enhance the audit program and CAPA effectiveness.
• Establish staff performance goals and develop the department.
• Promote a culture of high performance and quality.

Skills

Leadership

Auditing

Problem solving

Communication

Project management

Analytical thinking

Education

Bachelor’s degree in Life Sciences or Engineering

ASQ CQE/CRE/CQA certification (preferred)

Tools

MS Office

Job description

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.

DUTIES AND 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.

EXPERIENCE AND QUALIFICATIONS

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

KNOWLEDGE, SKILLS AND ABILITIES

• 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.

PHYSICAL DEMANDS

• This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office and travel as needed.
• While performing the duties of this job, the individual is frequently required to sit and stand for long periods. The individual is occasionally required to walk; use hands and fingers to operate, handle, or feel objects, tools, or controls; reach with hands and arms.

WORK ENVIRONMENT

This position performs duties in a standard office environment and requires up to 30% travel to supplier sites.

COMPENSATION SUMMARY

The annual base salary for this position ranges from $116,600 to $177,800. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate’s knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.

BENEFITS SUMMARY

At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.

EEO STATEMENT

MSD is an Equal Opportunity Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO statement, please visit here. Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.