Quality Engineer

Quality Engineer

The Quality Engineer supports manufacturing and new product development by leading validation activities, driving root cause analysis, and implementing robust quality systems. This role develops and maintains validation documentation and SOPs, provides statistical analysis and reporting, and partners with internal teams and customers to ensure processes, equipment, and products consistently meet defined quality standards. The Quality Engineer also plays a key role in continuous improvement initiatives and in building quality capability across the organization through training and coaching.

Responsibilities

• Facilitate and maintain comprehensive validation project documentation for equipment, processes, and related systems.
• Develop and execute validation protocols (IQ/OQ/PQ) for equipment, sanitation, facilities, software, and manufacturing processes.
• Collaborate with customers on equipment and process validation activities to ensure alignment with their requirements and quality standards.
• Serve as the database administrator for InfinityQS Statistical Process Control (SPC) software, ensuring data integrity and effective system use.
• Provide statistical analysis support for manufacturing operations, new product development projects, trials, and validation activities.
• Conduct quality and engineering studies to support manufacturing operations and improve process capability and product quality.
• Develop, implement, and maintain Standard Operating Procedures (SOPs) related to validation and risk management.
• Monitor, analyze, and prepare Key Performance Indicators (KPIs) for major customers, providing clear insight into quality and process performance.
• Lead Corrective Action and Preventative Action (CAPA) activities, including facilitating root cause investigations and implementing effective corrective measures.
• Apply sound investigation and problem-solving techniques to resolve quality and process issues within the manufacturing plant.
• Train and coach associates on quality topics such as Statistical Process Control (SPC) and CAPA methodologies to build quality awareness and competency.
• Drive continuous improvement initiatives with internal teams and external partners to enhance product quality, process efficiency, and customer satisfaction.

Essential Skills

• Proven experience in quality engineering within a manufacturing environment.
• Hands-on experience with validation activities, including the development and execution of IQ, OQ, and PQ protocols.
• Strong knowledge of process validation principles and practices.
• Demonstrated ability to perform root cause analysis and apply structured problem-solving methods.
• Proficiency with Statistical Process Control (SPC) tools and techniques.
• Experience administering or working extensively with InfinityQS or similar SPC software platforms.
• Ability to develop and maintain SOPs related to validation and risk management.
• Strong analytical skills with the ability to perform statistical analysis to support manufacturing, NPD, trials, and validations.
• Experience leading or facilitating CAPA activities from issue identification through to effective closure.
• Effective communication and training skills, with the ability to explain quality concepts such as SPC and CAPA to associates at various levels.

Additional Skills & Qualifications

• Validation of equipment, sanitation, facilities, software, and processes.
• Experience collaborating directly with customers on validation projects and quality initiatives.
• Familiarity with monitoring and reporting Key Performance Indicators (KPIs) for major customers.
• Demonstrated ability to work cross-functionally with internal teams and external partners on continuous improvement initiatives.
• Strong documentation skills, with attention to detail in validation records, SOPs, and quality reports.
• Comfort working in a data-driven environment and using statistical insights to inform decisions and improvements.

Work Environment

The role operates in a manufacturing-focused environment that combines time on the production floor with office-based analytical and documentation work. You will regularly interact with production, engineering, and quality teams, as well as collaborate with external partners and customers on validation and continuous improvement initiatives. The position involves working with SPC software tools such as InfinityQS, reviewing process data, and participating in investigations and improvement projects within an active plant setting. Standard business hours typically apply, with flexibility as needed to support validation activities, trials, and key manufacturing operations.

Job Type & Location

This is a Contract to Hire position based out of Morristown, TN.

Pay and Benefits

The pay range for this position is $85000.00 - $120000.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Morristown, TN.

Application Deadline

This position is anticipated to close on Jun 3, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.