Quality Engineer

Job Description

Job Description

Job Title: Quality Engineer

Job Description

The Quality Engineer plays a key role in supporting global quality teams by strengthening quality systems, driving continuous improvement, and ensuring strict compliance with FDA and ISO regulatory standards within a medical device manufacturing environment. This role focuses on developing, installing, and revising validation procedures and protocols so that products meet regulatory agency requirements, internal company standards, and current industry practices. The Quality Engineer contributes across the full product lifecycle, from design and development through routine production, and serves as a subject matter expert for validation and risk management programs while reporting to the Quality Manager.

Responsibilities

• Lead the implementation of methods and procedures for inspecting, testing, and evaluating new and transferred products, including executing line trials, conducting process risk analyses, and participating in design and process validations to define appropriate sampling plans for validations and routine production.
• Collaborate with Quality Control, Quality Assurance, Operations, Engineering, Customer Service, Maintenance, and R&D teams to design and plan validation activities, write protocols, execute tests, document results, prepare reports, and secure required approvals for all validation activities, including product processing, product packaging, and utilities.
• Maintain the cleaning validation matrix and evaluate new products against the matrix to determine the appropriate level of cleaning validation required.
• Work closely with Operations, Engineering, and R&D to manage all qualification activities for newly purchased equipment, including Installation Qualification (IQ) and Operational Qualification (OQ), and develop and maintain the validation master plan, qualification schedule, and validation schedule.
• Ensure validation and qualification projects are structured in accordance with FDA regulatory guidelines and communicate validation project status and timelines regularly to Quality Management.
• Resolve complex technical issues during product and process development by applying statistical techniques and analysis to improve the quality system and overall product performance.
• Perform risk management activities, including the development and execution of Failure Modes and Effects Analyses (FMEA).
• Recommend and initiate specification and process changes based on statistical analysis of product performance to ensure product safety, efficacy, and quality.
• Review, develop, revise, and approve quality-related documents, procedures, and records as needed to maintain an effective quality management system.
• Manage the laboratory function, including supervising two direct reports and overseeing day-to-day lab activities.
• Manage and track accelerated and real-time stability studies, summarize results in clear reports, and share findings with customers as appropriate.
• Monitor stability data, identify out-of-specification results, and promptly alert R&D and relevant stakeholders to initiate appropriate actions.
• Support internal and external compliance audits with regulatory agencies and serve as the subject matter expert for validation and risk management programs.
• Act as an internal auditor by planning and conducting internal audits to verify compliance with quality management system and regulatory requirements.
• Assist in investigations of product complaints, including root cause analysis, and support the development and implementation of corrective and preventive actions (CAPA).
• Support quality teams in implementing actions, reviewing procedures, and embedding continuous improvement initiatives within the quality system.
• Conduct training for personnel on quality systems, validation, risk management, and related procedures to ensure understanding and compliance.
• Maintain the integrity of the quality system, product design, and customer product requirements while fostering a strong culture of customer focus.
• Enforce a culture of compliance and performance in alignment with the quality management system, medical device regulations, and applicable standards.
• Perform other work-related duties as assigned by the Quality Manager to support departmental and organizational objectives.

Essential Skills

• Proven ability to maintain the integrity of the quality system, product design, and customer requirements while promoting a strong customer-focused culture.
• Demonstrated capability to enforce compliance with quality management systems and regulatory requirements, particularly within medical device manufacturing.
• Strong problem-solving skills and advanced statistical analysis capabilities using quality engineering tools such as fishbone diagrams, Pareto charts, cause-and-effect matrices, hypothesis testing, control charts, ANOVA, Design of Experiments (DOE), sampling methods, and process capability analysis.
• Experience in project specification, justification, and change management, with the ability to implement and execute continuous improvement initiatives using Lean Six Sigma principles.
• In-depth knowledge of medical device regulations, including FDA 21 CFR Part 820, ISO 13485, ISO 9001, and Good Manufacturing Practice (GMP) requirements.
• Practical experience in project management, including managing multiple projects simultaneously, with strong report writing and presentation skills.
• Demonstrated performance and application of Design Control principles for medical devices, including documentation and validation of design inputs, outputs, and changes.
• Ability to read, analyze, and interpret scientific and technical information, standards, and regulatory guidance.
• Ability to respond professionally to inquiries or complaints from customers, regulatory agencies, and internal stakeholders at healthcare-related sites.
• Strong communication skills with the ability to effectively present information and provide training to team members at various levels.
• Ability to comprehend and apply statistical principles, including statistical process control (SPC), capability indices (Cpk/Ppk), Production Part Approval Process (PPAP), Acceptance Quality Limits (AQL), and operating characteristic (OC) curves.
• Proven ability to define problems, collect relevant data, establish facts, perform root cause analysis, and draw valid conclusions.
• Previous quality engineering experience in the medical device manufacturing industry, with demonstrated compliance to 21 CFR Part 820, ISO 9001, Medical Device Directive (MDD), and related standards.
• Experience working in medical device manufacturing environments, including clean room suites and sterilization processes, is a distinct advantage.
• Bachelors degree in Engineering, Chemistry, Physics, Biology, or another Natural Science discipline.
• Proficiency with personal computers and standard office software, combined with strong verbal and written communication skills.
• Experience using Minitab or similar statistical analysis software for data analysis and reporting.
• Ability to work independently using initiative while also demonstrating strong teamwork and collaboration skills.

Additional Skills & Qualifications

• Certified Quality Engineer (CQE) or equivalent professional certification is highly desirable.
• Experience with risk management in accordance with ISO 13485 and ISO 9001, including formal risk assessment methodologies.
• Familiarity with pressure sensitive adhesive tape standards and procedures in a quality control environment, including laboratory testing methods.
• Hands-on experience with supplier quality, quality assurance, and quality control in manufacturing settings.
• Knowledge of clean room environments and clean room suite operations within medical device or healthcare-related manufacturing.
• Experience with sterilization and sterilization validation processes, including technologies such as electron beam (e-beam).
• Working history in root cause analysis and structured problem-solving methodologies, including the use of PPAP and other automotive or medical device approval processes.
• Experience supporting or leading validation activities, including equipment, process, and cleaning validations.
• Understanding of sustainable packaging, filtration, and healthcare-related applications is beneficial due to the companys diversified end markets.
• Ability to contribute to innovation and performance enhancement by leveraging materials science, polymers, fibers, and resins across multiple stages of the value chain.

Work Environment

This role operates in both office and manufacturing environments within a global specialty materials organization. The work setting is typically quiet to moderate in noise, with periods spent on the manufacturing floor where appropriate protective head coverings may be required. The position involves frequent sitting and communication, as well as occasional standing, walking, and manual handling of objects, tools, or controls. The role may require lifting up to 20 pounds. Close, distance, and color vision are necessary to inspect products, review data, and perform laboratory and validation activities. Work may be performed in clean room environments and laboratories where precision, cleanliness, and adherence to safety and quality procedures are critical. The companys culture emphasizes innovation, continuous improvement, and customer focus, offering exposure to advanced materials technologies, global manufacturing practices, and cross-functional collaboration. Team members benefit from paid holidays and paid time off, and work with modern equipment and statistical tools such as Minitab to support validation, risk management, and quality engineering tasks.

This is a Contract position based out of Knoxville, TN.

The pay range for this position is $50.00 - $70.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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)

This is a Contract position based out of Knoxville, TN.

This position is anticipated to close on Nov 12, 2026.

This is a fully onsite position in Knoxville,TN.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 View email address on ziprecruiter.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.