Quality Engineer

Job Title:

Quality Engineer Job Description

The Quality Engineer evaluates and investigates product complaints and nonconformances, drives corrective and preventive actions, and supports new product introduction to ensure consistent compliance with quality standards. This role serves as a key liaison between the plant, customers, and internal teams, authoring and maintaining quality system documentation, performing internal audits, and promoting continual improvement in processes and product design within a regulated manufacturing environment.

• Perform and document evaluations and investigations resulting from customer complaints, product nonconformances, and corrective and preventive actions (CAPA).

• Deploy formal root cause analysis methods and tools to identify underlying issues and implement effective corrective actions.

• Validate and approve Production Part Approval Process (PPAP) submissions for new product introduction (NPI) programs.

• Serve as a representative of the plant to customers, providing professional communication and support on quality-related topics.

• Collaborate with cross-functional internal groups to respond to product inquiries, resolve issues, and support continuous improvement initiatives.

• Disposition returned products in accordance with established procedures and quality system requirements.

• Perform internal audits in accordance with ISO 9001 and other applicable quality standards to ensure ongoing compliance.

• Ensure continual improvement in process and product design by identifying opportunities, recommending changes, and supporting implementation.

• Participate in customer audits and notified body audits, providing documentation, explanations, and follow-up actions as needed.

• Author and maintain quality management system (QMS) documents, specifications, and work instructions that meet and sustain quality standards.

• Track plant performance against quality requirements using established measurement standards and metrics.

• Verify the effectiveness of CAPA actions by reviewing data, monitoring outcomes, and updating records.

• Interact with customers in a professional manner to address quality concerns, provide status updates, and support long-term relationships.

• Support process validation, advanced product quality planning (APQP), and related activities for new product development and ongoing production.

• Contribute to a culture of quality and continuous improvement within a manufacturing environment, particularly for medical and electro-mechanical products.

• 1–3 years of experience in a quality or regulatory affairs role.

• Hands‑on ownership of CAPA activities, including investigation, implementation, and verification of effectiveness.

• Strong root cause analysis skills using formal methodologies and tools.

• Experience with internal auditing, preferably to ISO 9001 or similar quality management system standards.

• Experience with complaint and nonconformance management in a manufacturing environment.

• Familiarity with PPAP and APQP processes for new product introduction and ongoing production.

• Exposure to medical device or GMP‑related industries, with understanding of regulated quality systems.

• Knowledge of process validation in a manufacturing or product development context.

• Proficiency with Microsoft Office Suite (such as Word, Excel, and PowerPoint) for documentation and reporting.

• Strong organizational skills with the ability to manage multiple tasks and priorities.

• Strong problem‑solving skills with a quality‑and‑results‑oriented mindset.

• Ability to interact with customers in a professional and collaborative manner.

• Comfort working in or around production environments within a manufacturing facility.

• Knowledge of GMP‑related industries is preferred.

• Experience with quality system standards, including ISO 9001, is preferred.

• ASQ Certified Quality Engineer (CQE) or ASQ Certified Quality Auditor (CQA) certification is preferred.

• Experience in a medical device or healthcare‑related manufacturing environment is an advantage.

• Familiarity with electro‑mechanical products, such as surgical medical carts, is beneficial.

• Exposure to new product…