Quality Engineer

Job Summary:

The Quality Engineer plays a pivotal role in ensuring that products meet internal quality standards and comply with all applicable medical device regulatory requirements. This position supports contract manufacturing operations, addresses client quality expectations, and promotes ongoing improvements in processes, products, and systems.

Key Responsibilities:

• Ensure adherence to relevant quality standards and regulations, such as ISO 13485 and FDA 21 CFR Part 820.
• Collaborate with contract manufacturing partners to understand and fulfill quality requirements.
• Address customer feedback, audit outcomes, and concerns in a timely and professional manner.

• Investigate nonconformances and lead root cause analyses.

• Implement corrective and preventive actions (CAPAs) and monitor their effectiveness.

• Maintain detailed records of quality incidents and resolutions.

• Lead or assist in validation of equipment, manufacturing processes, and testing methods.
• Prepare and manage validation documentation in accordance with regulatory expectations.
• Draft, review, and approve quality-related documentation such as standard operating procedures (SOPs), work instructions, protocols, reports, and engineering change orders.
• Collaborate with procurement and supplier quality teams to qualify new suppliers.

• Participate in supplier audits and resolve supplier-related quality concerns.

• Drive process and quality improvement initiatives using methodologies such as Lean, Six Sigma, or other continuous improvement tools
• Contribute to preparation for internal, customer, and third-party audits.

• Assist with audit execution and ensure timely closure of any findings.

Minimum Qualifications:

• Bachelors degree in engineering or a related discipline.

• Three to five years of experience in quality engineering, or an equivalent combination of education, certifications, and professional experience.

Knowledge, Skills, and Abilities:

• Proficiency in engineering principles and geometric dimensioning and tolerancing (GD&T).

• Skilled in using precision measurement tools (e.g., calipers, micrometers, depth gauges, indicators, Go/No Go gauges).

• Strong understanding of ISO 13485 and FDA 21 CFR Part 820.

• Working knowledge of software tools including Microsoft Office, Adobe PDF, SolidWorks, metrology software, and ERP systems.

• Proficiency in mathematical concepts including algebra, geometry, and metric conversions for material specification calculations.

• Ability to set priorities and drive projects to meet quality and customer goals.

• Capable of working independently with minimal supervision.

• Ability to read and interpret engineering blueprints.

• Strong interpersonal skills and the ability to work collaboratively with cross-functional teams.

• Adaptability to evolving technologies and quality practices.

• Effective written and verbal communication skills in English.