Quality Engineer

Job Title: Quality Engineer This Quality Engineer role supports a specialized manufacturing facility that produces precision cutting tools used in ophthalmology. You will own and develop the quality standards for the site, working across all aspects of quality in a hands-on manufacturing environment. This position offers the opportunity to build and refine quality systems, lead investigations, manage documentation, and collaborate with a broader quality team across multiple locations while being the primary Quality Engineer on site. Responsibilities + Develop, implement, and maintain an Acceptable Quality Level (AQL) plan for complaint investigations, including collecting and analyzing data from the production line to support investigation conclusions. + Lead and support complaint handling activities, including intake, evaluation, coordination of investigations, maintenance of complaint records, preparation and presentation of complaint trending reports, and regulatory reporting of device incidents. + Create, implement, and maintain process control plans to ensure robust and compliant manufacturing processes. + Focus daily on improving, implementing, and maintaining the quality system in the manufacturing environment, including calibration, in-process and final product inspections, product controls, and final product release activities. + Manage and oversee document control activities, ensuring accurate generation, review, approval, and maintenance of quality and engineering documents. + Assist with Material Review Board (MRB) activities, ensuring appropriate trending, timely closure of issues, and proper disposition of nonconforming materials, and drive continuous improvement initiatives based on MRB data. + Support the development and maintenance of quality system documents and records, including Device Master Records, Technical Files, and QA System Release Records. SKILLS NEEDED: + Bacheloru2019s degree in engineering or an equivalent combination of technical certification and relevant work experience. + At least 5 years of experience in quality engineering, ideally within medical device, pharmaceutical, or life sciences manufacturing. + Minimum of 5 years of experience working in a manufacturing environment. + At least 5 years of experience with statistical process control, including the ability to collect, analyze, and interpret process data. + Demonstrated experience performing process capability studies to quantify, interpret, and improve how well processes meet requirements. + Previous experience creating and implementing Process Control Plans in a manufacturing setting. + Proven problem-solving experience, including the use of structured methodologies such as Six Sigma or similar approaches. + Experience with supplier quality or supplier oversight, including participation in supplier qualification or assessments. + Proficiency with quality audits, including internal or external audits in a regulated environment. + Strong project management skills with the ability to manage multiple tasks and work effectively in cross-functional teams. + Proficiency in Microsoft Office applications and statistical software programs, along with comfort working with standard operating systems. + Ability to work independently as the primary Quality Engineer on site while collaborating effectively with remote quality teams. + Strong analytical and critical thinking skills, with the ability to translate data into actionable improvements. + Adaptable mindset and curiosity about how processes work, with a willingness to learn and take on diverse responsibilities in a small-site environment. + Clear written and verbal communication skills for documentation, reporting, and cross-functional collaboration. Additional Skills & Qualifications + Previous experience in a medical device, pharmaceutical, or life sciences company is highly desirable. + Experience working within globally regulated environments, including exposure to EU Notified Bodies and FDA inspections, is a plus. + Familiarity with quality system elements such as complaint handling, CAPA, Management Review, internal audits, and training programs. + Experience with validation studies and quality projects to support regulatory compliance. + Ability to conduct or support external quality assessments of distributors and suppliers. + Spanish language skills are a plus and may support communication with diverse teams or suppliers. + Experience in precision manufacturing or production of highly regulated products is beneficial. + Comfort working in a growing organization with a collaborative culture and a close-knit team environment. Work Environment This role is based at a small manufacturing facility of approximately 40 employees, where you will serve as the primary Quality Engineer on site. You will have an office space but will spend significant time on the manufacturing floor to observe processes, interact with production personnel, and gather data. The environment is hands-on, collaborative, and fast-paced, with a strong emphasis on teamwork between engineering, manufacturing, and quality. Core working hours are 7:00 a.m. to 3:30 p.m., with flexibility to adjust start and end times as long as you are present for the majority of core hours. The typical workweek is approximately 40u201345 hours. After several months of onsite training and integration, a limited hybrid schedule may be possible. Travel requirements are low, up to approximately 5%, primarily for training or visits to other company locations. You will collaborate regularly with quality professionals located at other sites, such as those in St. Louis and Colorado, while enjoying the close-knit, small-company feel of the local facility within a larger, growing medical device organization. Job Type & Location This is a Contract to Hire position based out of Flint, MI. Pay and Benefits The pay range for this position is $45.00 - $52.00/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: u2022 Medical, dental & vision u2022 Critical Illness, Accident, and Hospital u2022 401(k) Retirement Plan u2013 Pre-tax and Roth post-tax contributions available u2022 Life Insurance (Voluntary Life & AD&D for the employee and dependents) u2022 Short and long-term disability u2022 Health Spending Account (HSA) u2022 Transportation benefits u2022 Employee Assistance Program u2022 Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Flint,MI. Application Deadline This position is anticipated to close on May 11, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, weu2019ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APACu2014with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at .

Created: 2026-04-30