Quality Engineer

ACTalent; Manchester (TN); Presencial; USD 80.000 - 85.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Healthcare plan

401(k) plan

Paid vacation

On-site facility

Descripción de la vacante

Actalent is seeking a Quality Engineer for a medical device manufacturing environment in Manchester, TN. The role focuses on driving continuous improvement, ensuring regulatory compliance, and strengthening quality systems across manufacturing operations.

You will analyze data, support CAPA and audits, and collaborate with cross-functional teams to enhance product reliability and process capability. This permanent onsite position offers comprehensive benefits.

Formación

• 35 years of experience in a quality engineering role within a regulated manufacturing environment (medical devices preferred).
• Knowledge of FDA QSR and risk management principles for medical devices or regulated products.
• Strong analytical and problem-solving skills with structured root-cause analysis.
• Experience with FMEA and SPC.
• Experience supporting internal audits in manufacturing or quality systems.
• Hands-on experience with manufacturing processes and quality control in production.
• Ability to work cross-functionally with engineering, manufacturing, and quality teams.
• Excellent verbal and written communication for client-facing stakeholders.

Responsabilidades

• Support and maintain standard quality manufacturing practices in FDA-regulated environments.
• Develop, implement, and improve quality systems and documentation.
• Lead or support CAPA processes for nonconformances.
• Collaborate on quality projects including process validation and risk management.
• Conduct internal quality audits and support regulatory inspections.
• Analyze quality data to drive continuous improvement initiatives.
• Review and approve batch records and change documentation.
• Apply QE tools like FMEA and SPC to reduce variation and improve reliability.
• Support shop-floor process improvements with production teams.
• Manage quality-related projects and keep stakeholders informed.
• Interface with clients on quality matters and provide technical support.

Conocimientos

Quality engineering

FDA QSR knowledge

Root cause analysis

FMEA

SPC

Audit experience

Cross-functional collaboration

Customer-facing communication

Educación

Bachelor's degree in engineering or related field

7+ years experience in lieu of degree

Herramientas

PPAP experience

CNC-based manufacturing processes

Descripción del empleo

Job Title: Quality Engineer Medical Device Manufacturing

Job Description

This Quality Engineer role offers the opportunity to support a medical device manufacturing environment by driving continuous improvement and ensuring strict compliance with regulatory requirements. You will work closely with cross-functional teams to maintain robust quality systems, support manufacturing operations, and enhance product reliability through data-driven decision-making and proactive quality initiatives.

Responsibilities

• Support and maintain standard quality manufacturing practices in compliance with FDA regulations and applicable quality standards.

• Assist in the development, implementation, and continuous improvement of quality systems, procedures, and documentation.

• Participate in root cause analysis activities and lead or support corrective and preventive action (CAPA) processes to address nonconformances and recurring issues.

• Collaborate with cross-functional teams on quality-related projects, including process validation, risk management, and new or existing product development initiatives.

• Conduct internal quality audits to verify compliance with internal procedures and regulatory requirements, and support external regulatory inspections as needed.

• Analyze quality data and metrics, such as defect trends and process capability, to identify opportunities for improvement and drive continuous improvement projects.

• Review and approve manufacturing and quality documentation, including batch records, change documentation, and other controlled records.

• Apply quality engineering tools such as FMEA, SPC, and structured root cause analysis to improve process capability, reduce variation, and enhance product reliability.

• Support manufacturing process improvements on the shop floor, working closely with production teams to resolve quality issues and optimize processes.

• Manage and support quality-related projects, ensuring deliverables are completed on time and effectively communicated to stakeholders.

• Interface with clients and external stakeholders on quality matters, providing clear, professional communication and technical support when required.

Essential Skills

• 35 years of experience in a quality engineering role within a regulated manufacturing environment, preferably in medical device manufacturing.

• Working knowledge of FDA Quality System Regulation (QSR) and risk management principles applicable to medical devices or other regulated products.

• Strong analytical and problem-solving skills, with demonstrated experience using structured root cause analysis methods.

• Proficiency with quality engineering tools such as Failure Modes and Effects Analysis (FMEA) and Statistical Process Control (SPC).

• Experience supporting or conducting internal audits in a manufacturing or quality systems environment.

• Hands-on experience with manufacturing processes and quality control in a production setting.

• Ability to work effectively in cross-functional teams and collaborate with engineering, manufacturing, and quality personnel.

• Strong verbal and written communication skills, including the ability to communicate clearly with client-facing stakeholders.

• Ability to work approximately 4550 hours per week, as required by production and project demands.

Additional Skills & Qualifications

• Bachelors degree in engineering, life sciences, or a related field preferred.

• Candidates with 7+ years of relevant quality engineering experience may be considered in lieu of a degree.

• Experience in medical device manufacturing, including familiarity with relevant standards such as ISO 9001, is strongly preferred.

• Experience with Production Part Approval Process (PPAP) in a manufacturing environment.

• Experience working with CNC-based manufacturing processes is beneficial.

• Strong organizational skills and attention to detail, with the ability to manage multiple tasks and documentation requirements in a regulated environment.

Work Environment

The role is based in a manufacturing plant environment with extensive use of CNC machines and other production equipment. You will spend significant time on the shop floor, collaborating with production and engineering teams to monitor processes and address quality issues in real time. The position typically requires working 4550 hours per week to support production schedules, project timelines, and audit or inspection activities. The environment is fast-paced and project-driven, with full benefits offered and a strong focus on continuous improvement, regulatory compliance, and cross-functional teamwork.

Job Type & Location

This is a Permanent position based out of Manchester, TN.

Pay and Benefits

The pay range for this position is $80000.00 - $85000.00/yr.

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.

Health & Wellness Generous healthcare plan that rewards positive lifestyle choices Air-conditioned, clean manufacturing spaces for comfort on the job Supportive environment focused on employee health and safety Financial & Retirement Competitive pay structure Retirement benefits (details not fully disclosed, but commonly include 401(k) plans) Time Off & Work-Life Balance Paid vacation and time off policies Flexible attendance system (described as lenient by some employees) Work-life balance rated moderately well by employees Career Development Opportunities for internal advancement On-the-job learning and training programs Roles available across engineering, manufacturing, and quality assurance Company Culture Family-run business with a culture of trust, fairness, and respect Emphasis on doing right by associateswere in this together mentality Positive reviews from employees who value the team atmosphere and leadership support

Job Type & Location

This is a Permanent position based out of Manchester, TN.

Application Deadline

This position is anticipated to close on Nov 20, 2026.

Workplace Type

This is a fully onsite position in Manchester,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 [e-mail] 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.