Engineer III, Quality

Meso Scale Diagnostics LLC; Rockville (MD); Presencial; USD 101.000 - 155.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical coverage

Dental coverage

Vision coverage

401(k) matching

Paid vacation

Descripción de la vacante

Meso Scale Diagnostics LLC seeks a Quality Engineer III to lead QA activities and mentor junior staff in Rockville, MD. The role drives design controls, validation strategies, and continual improvement within MSD's Quality System, ensuring compliance with QSR/ISO standards and regulatory certifications.

You will direct CAPA programs, audits, and supplier quality investigations, while collaborating across NPD and manufacturing to uphold product quality and regulatory readiness.

Formación

• Bachelor's degree in a technical/scientific/engineering discipline required.
• Minimum of 7 years of experience in medical devices, in vitro diagnostics, pharmaceuticals or related industry.
• Experience with developing, implementing and maintaining Quality System compliance strongly preferred.
• Experience planning and implementing quality plans and programs preferred.
• Relevant ASQ Certification (e.g. CQE, CRE, CQA) is beneficial.

Responsabilidades

• Participate on New Product Development (NPD) project teams.
• Review deliverables of the design and development process for conformity to requirements.
• Oversee design history files and risk management files.
• Oversee supplier management activities for NPD projects.

Conocimientos

Quality systems

Analytical skills

Communication skills

MS Office

Problem solving

Educación

Bachelor's degree in technical/scientific/engineering

Master's degree

Herramientas

MS Office Suite

Descripción del empleo

Description

POSITION SUMMARY

The Quality Engineer III serves as a subject matter expert for planning and directing activities concerned with development, application and maintenance of quality standards for processes, materials and products in accordance with quality programs, plans, SOPs and policies of the company's Quality System. This position is also responsible for mentoring and/or supervising more junior QA team members and ensuring compliance with corporate policies and the company's active regulatory certifications.

DUTIES AND RESPONSIBILITIES

• New Product Development
  • Participate on New Product Development (NPD) project teams.
  • Ensure compliance to the Quality Management System (QMS) processes and procedures and provide guidance to project teams on the elements of design controls as defined by the QMS.
  • Review deliverables of the design and development process for conformity to internal and external requirements.
  • Oversee resources that maintain the design history files and risk management files.
  • Oversee supplier management activities for NPD projects.
• Validation Support
  • Serve as Quality representative on validation activities (e.g. equipment, process, assay, spreadsheet, software, facilities and utilities)
  • Support the projects under the Master Validation Plan.
  • Develop strategies to ensure that products are manufactured in accordance with appropriate current industry standards and provide guidance to resources who revise validation procedures/protocols
  • Compile and analyze validation data, prepare documentation, and make recommendations for changes and/or improvements, as needed for validation of complex projects and oversee resources performing these activities for lower complexity projects.
  • Define, document, and continuously improve verification plans and protocols including conducting peer reviews and maintaining traceability to requirements.
  • Analyze data by completing hypothesis, normal distribution, and process capability analysis tests.
• Quality Assurance
  • Lead supplier quality related investigations.
  • Support the Material Review Board by recommending or reviewing the disposition of Non-Conforming Material.
  • Lead internal and supplier audits as needed. Ensure that audits are properly performed, documented, and completed in accordance with the annual audit procedure/schedule.
  • Assist during external audits associated with MSD's active regulatory certifications as well as customer audits.
  • Direct the need for Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects. Ensure that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time.
  • Generate and analyze metrics needed to measure the effectiveness of the QMS.
• Specific duties may vary depending upon departmental requirements; engineers at this level may have either broad responsibilities in the areas described above or more focused responsibilities requiring greater subject matter expertise.

EXPERIENCE AND QUALIFICATIONS

• Bachelor's degree in a technical/scientific/engineering discipline is required.
• Master's degree is preferred
• Minimum of 7 years of experience in medical devices, in vitro diagnostics, pharmaceuticals or related industry is required, in positions of increasing responsibility.
• Experience with developing, implementing and maintaining Quality System compliance strongly preferred.
• Experience planning and implementing quality plans and programs preferred.
• Experience in mentoring/training preferred.
• Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred, including but not limited to Measurement System Analysis, SPC, DOEs, and Reliability.
• Relevant ASQ Certification (e.g. CQE, CRE, CQA) is beneficial.

KNOWLEDGE, SKILLS AND ABILITIES

• Intermediate level knowledge of ISO 9001 quality system requirements is required
  • Working knowledge of FDA's Quality System requirements (QSR) and ISO 13485 standard is preferred.
• Strong quality fundamentals and analytical background
  • Logical problem solving through TQM, team building and quality systems tools and methods
  • Demonstrated ability to organize and move project tasks forward in an orderly and structured fashion
• Excellent oral and written communication and interpersonal skills
  • Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of quality system data
  • Expert level documentation/technical writing skills
• Proficiency in MS Office Suite
  • Capacity to learn additional software applications as the need arises
• A wide degree of creativity and latitude is expected including the ability to multi-task and work productively in demanding manufacturing and research environments 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.

WORK ENVIRONMENT

• This position is performed in a standard office environment.

COMPENSATION SUMMARY:

The annual base salary for this position ranges from $101,400 to $154,700. 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 click on the following link: https://www.mesoscale.com/en/our_company/careers/equal_employment_opportunity_statement.

Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.

Education

Bachelors of Science (required)

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.