Manufacturing Quality Engineer

The Quality Engineer serves as the primary liaison between the company and its customers regarding product quality concerns. This role ensures customer satisfaction by managing quality issues, driving root cause analysis, implementing corrective actions, and continuously improving processes to meet customer expectations and industry standards.

The Quality Engineer will develop all protocols for FAT’s (Factory Acceptance Test), HAT’s (Hardware Acceptance Test) and other Customer required documents along with conducting the above testing with or for the customer.

• Writing technical papers which include Factory Acceptance Test, Hardware Acceptance Test and other quality protocols as required by the customer.
• Act as the main point of contact for customer quality-related inquiries and concerns.
• Lead investigations into customer complaints, non-conformances, and warranty issues.
• Coordinate and execute root cause analysis (e.g., 5 Whys, Fishbone, DMAIC) and develop effective corrective and preventive actions (CAPA).
• Prepare and submit customer-required documentation such as 8D reports and quality alerts.
• Monitor and report on customer satisfaction metrics, including scorecards and audit results.
• Collaborate with internal teams (Engineering, Manufacturing, Supply Chain) to resolve quality issues and improve product performance.
• Support customer audits and visits, ensuring compliance with quality standards and expectations.
• Drive continuous improvement initiatives to enhance product quality and reduce defects.
• Maintain accurate records of customer interactions, complaints, and resolutions.
• Ensure compliance with ISO standards and other applicable regulations.

• Bachelor’s degree in Engineering, Quality, or a related field.
• 3+ years of experience in a quality engineering role, preferably in a manufacturing Bioprocessing environment.
• Strong knowledge of quality tools and methodologies (FMEA, Control Plans and Inspection reports).
• Experience with customer-facing roles and managing quality issues.
• Proficiency in using quality management systems (QMS) and data analysis tools.
• Excellent communication, problem‑solving, and interpersonal skills.
• Certifications such as CQE, Six Sigma, or Lean are a plus.

• Experience with OEM or Tier 1 Bio-Processing Customers a plus.
• Familiarity with industry-specific standards (ISO 9001).
• Ability to travel to customer sites as needed.
• Lifting of 50lbs.
• Working in plant to conduct testing.

Medical, dental, and vision insurance eligibility. 401(k) with company match. Paid vacation, paid holidays, life insurance, and voluntary benefits.