Description

KEY PURPOSE OF ROLE

Quality Engineer will support all quality teams with knowledge in quality systems and continuous improvement while assuring compliance with regulatory requirements for FDA and ISO standards. The Quality Engineer is responsible for developing, preparing the installation, and/or revising test validation procedures/protocols to ensure the appropriate regulatory agency validation requirements, internal company standards, and current industry practices manufacture the product. The Quality Engineer reports to the Quality Manager.

KEY RESPONSIBILITIES

•\tSupport new and transferred products by leading efforts of implementation of methods and procedures for inspecting, testing, and evaluating product including executing line trials, process risk analysis; and participating in design and process validations to determine appropriate sampling plans for validations and routine production

•\tInterfaces with personnel in Quality Control, Quality Assurance, Operations, Engineering, Customer Service, Maintenance, and R&D teams to design, plan, write protocols, execute document results, writes reports, and gain the required approvals for all validation activities. Validation activities include, but are not limited to, product processing, product packaging, and utilities.

•\tMaintains the cleaning validation matrix and evaluates new products against the matrix to determine the level of validation required.

•\tCollaborates with Operations, Engineering, and R&D and manages all Qualification activities for newly purchased equipment (Installation, Operational Qualification). Develops and maintains validation master plan, qualification, and validation schedule. Ensures FDA regulatory guidelines structure validation/qualification projects and timelines. Informs Quality Management of validation projects on a regular basis.

•\tResolve difficult technical issues during product and process development using statistical techniques and analysis to improve the Quality system.

•\tPerforms Risk Management activities, including FMEA’s

•\tRecommends and initiates specification and process changes based on a statistical analysis of products to ensure the product’s safety, efficacy, and quality.

•\tReview, develop, revise, and approve quality-related documents as needed.

•\tManage the lab with two direct reports

•\tManage and track the accelerated and real-time stability samples

•\tDraft summary reports of the results and share them with the customers

•\tMonitor stability results and alert R&D if results are out of spec

•\tSupport internal and external compliance audits with regulatory agencies and be the subject matter expert for the validation and risk management programs.

•\tServes as an auditor for internal audits.

•\tAssist in investigations regarding product complaints and correct/preventive actions.

•\tAssists the quality teams as needed actions, reviews, and implementation procedures.

•\tConducts training of personnel as needed.

•\tPerforms other work-related duties as assigned by the Quality Manager.

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VIRTUES AND TALENTS

The role incumbent will demonstrate the relevant talents for the role and will display the virtues aligned with our principles:

Essential Skills/Experience/Qualifications:

Essential Skills:

•\tMaintain the integrity of the quality system, product design, and customer product requirements while maintaining a culture of customer focus.

•\tEnforce a culture of compliance and performance to the quality management system and regulatory requirements.

•\tStrong problem-solving and statistical analysis skills using a variety of quality engineering tools such as fish-bone, Pareto charts, C&E matrix, hypothesis testing, control charting, ANOVA, DOE, sampling methods, and process capability

•\tProject specification, justification, and change management

•\tCan implement and execute continuous improvement initiatives using Lean Six Sigma principles

•\tMedical Device Regulations Knowledge; FDA 21 CFR 820, ISO13485, ISO9001, and GMP experience

•\tProject management with excellent report writing and presentation skills

Essential experience:

•\tWorking knowledge of FDA 21 CFR Parts 820, ISO 13485, and ISO 14971 preferred.

•\tPractical experience in successfully managing multiple projects simultaneously.

•\tDemonstrated performance and application of Design Control, particularly regarding Medical Devices.

•\tAbility to read, analyze and interpret standard scientific and technical information.

•\tAbility to respond to common inquiries or complaints from customers, regulatory agencies, or members of the Mativ HC sites.

•\tAbility to effectively present information to Team Members with an emphasis on training.

•\tAbility to comprehend and apply principles of statistics with demonstrated application of statistical theory and sampling plans (e.g., SPC, Cpk/Ppk, PPAP, AQL, OC curves, etc.) preferred.

•\tAbility to define the problem, collect data, establish facts, and draw valid conclusions.

Essential Qualifications:

•\tPrevious Quality Engineering experience in the Medical Device manufacturing industry in compliance with 21 CFR 820, ISO 9001, MDD, and ISO 13485.

•\tExperience in Medical Device manufacturing would be a distinct advantage.

•\tBachelor’s degree in engineering/chemistry, physics, Biology, or Natural Sciences

•\tPC literate with good communication skills, both verbal and written. Minitab statistical analysis.

•\tThe ability to work using initiative when required but also showing aptitude as a team player.

Desirable Skills/Experience/Qualifications:

•\tCertified Quality Engineer

•\tRisk Management – 14971, ISO13485, and ISO9001

•\tFamiliarity with Pressure Sensitive Adhesive Tapes standards and procedures in a quality control environment, including laboratory testing.

WORK ENVIRONMENT / PHYSICAL DEMANDS

The physical demands described here must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

While performing the duties of this job, the employee is frequently required to sit and talk or hear and can lift to 20 lbs. The employee is occasionally required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls.

Specific vision abilities required by this job include close vision, distance vision, and color vision.

Pay and Benefits

The pay range for this position is $33.00 - $38.00/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 Knoxville,TN.

Application Deadline

This position is anticipated to close on Aug 7, 2025.

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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.