Quality Engineering Manager

MESO SCALE DIAGNOSTICS, LLC.; Washington, Tacoma (District of Columbia, WA, MD); On-site; USD 117,000 - 178,000; Full time

Benefits offered by this job

401(k) with company matching

Paid vacation

Paid holidays

Paid parental leave

Disability insurance

Group life insurance

Job summary

Meso Scale Diagnostics, LLC in the United States is seeking a senior leader to develop, implement, and maintain the design and development program within the quality management system.

This role leads the quality engineering team, drives design control for new products and changes, and ensures compliance with ISO 13485 and FDA expectations while supporting cross‑functional product development.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Biochemistry or Engineering.
• Minimum of eight years in a quality role supporting design control for multiple product types.
• Experience with FDA and/or ISO auditors preferred.
• Minimum of 2 years of management experience.

Responsibilities

• Maintain and continuously improve the design and development elements of the QMS and ensure compliance.
• Establish and monitor staff performance, set objectives and provide feedback.
• Promote a high performance culture focused on quality.
• Manage quality engineering team providing design control guidance for new products and changes.
• Develop, implement and maintain SOPs for the Design Control program.
• Manage product development and enhancement activities.
• Contribute to hardware, software and assay requirements for new products.
• Collaborate with cross‑department teams to support design, development, integration, transfer, production and after‑sales support.
• Duties may vary depending on departmental requirements.

Skills

ISO 13485 knowledge

Design controls

Mentoring teams

Leadership

Problem solving

Communication

MS Office Suite

Negotiation & mediation

Attention to detail

Education

Bachelor’s degree in Biology, Chemistry, Biochemistry or Engineering

Tools

MS Office Suite

Job description

This position is responsible for developing, implementing and maintaining a design and development program in compliance with corporate policies and the requirements of the quality management system.

DUTIES AND RESPONSIBILITIES

• Maintain and continuously improve the design and development elements of our quality management system and ensure that processes remain in compliance with company policies and other regulatory requirements as applicable.


• 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.


• Manage quality engineering team responsible for providing design control guidance and support for new product introductions and significant design changes.


• Develop, implement and maintain SOPs for the documentation and execution of the company’s Design Control program.


• Manage and participate in product development and product enhancement activities.


• Contribute to the development of hardware, software and assay requirements and specifications for new products.


• Work with cross-departmental teams to support the design, development, integration, transfer, production and after sales support of MSD software, instrumentation, associated test kits, consumables and reagents.


• 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 a quality role supporting design control activities for multiple or complex product types e.g. software, consumables, instruments is required.


• Experience working with FDA and/or ISO auditors is preferred.


• Minimum of 2 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.


• Advanced level knowledge of design control processes and best practices.


• Track record of successfully mentoring design and development teams with varying levels of knowledge and experience.


• 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 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.


• 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.

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/AA STATEMENT

MSD is an Equal Opportunity/Affirmative Action 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, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please visit here. Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.