Job Title: Quality Engineer

We are seeking a passionate Quality Engineer to join our team and help us drive excellence across product development and manufacturing. In this dynamic role, you will lead key initiatives such as part validation, qualification, and support for sustaining programs. You will also be the go-to expert for addressing customer quality concerns, collaborating closely with both production and engineering teams to find solutions and ensure we deliver the highest standards every time.

Responsibilities

• Participate in the organization’s overall Stage-Gate approach to product realization.
• Take responsibility for APQP and PPAP activities for new and changed programs as directed by the Quality & Regulatory Manager.
• Carry out Quality Planning including Process Flow Diagrams, Process FMEA, and Process Control Plan.
• Prepare work instructions and inspection instructions.
• Conduct PPAP/validation for purchased materials and components.
• Implement and report on pre-launch/early containment activity.
• Continually improve relationships and the company’s position with customers and suppliers through direct interface and strong leadership.
• Make dispositions on material placed on hold internally.
• Participate in the creation and management of CAPAs, SCARs, RMA activities, and sustaining programs.
• Write and issue Quality Alerts.
• Write and perform validation protocol.
• Work collaboratively with customers and employees to provide consultation and advice on quality issues.
• Serve as the primary contact for quality issues for assigned customers as directed by the Quality Assurance Manager. May be required to visit customer locations as needed.
• Conduct training related to the Quality Management System as requested.

• B.S Degree or equivalent work experience is required.
• 4 years of experience in a regulated manufacturing environment.
• Proficiency in ISO 9001, APQP, PPAP.
• Experience with SPC is preferred.
• Familiarity with ISO13485 or FDA regulations is preferred.
• Experience with Epicor or similar ERP systems is preferred.
• Print reading, cGMP/GDP, GD&T, and cosmetic specifications experience is preferred.
• Ability to manage multiple projects concurrently.
• Strong verbal and written communication skills with experience in Microsoft Suite.
• Experience with change control, revision change, and documentation.
• Ability to manage time effectively while handling multiple projects and responsibilities.

• Experience in medical device manufacturing, injection molding, and plastics injection molding.

The work environment includes desk work, working in the QE lab, and on the production floor. The company offers good benefits and is located on a large site with nice amenities.

Job Type & Location

This is a Permanent position based out of Port Richey, Florida.

Pay and Benefits

The pay range for this position is $85000.00 - $100000.00/yr.

401k
medical
dental
vision

Workplace Type

This is a fully onsite position in Port Richey,FL.

Application Deadline

This position is anticipated to close on Sep 29, 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.

Salary : $85,000 - $100,000