Sr Quality Engineer

Position Overview :

As a Quality Engineer, you will play a key role in ensuring that products and processes comply with regulatory and Client standards You'll collaborate cross-functionally to drive continuous improvement, support manufacturing, and ensure the highest levels of product quality and patient safety The role includes hands-on support in controlled environments, involvement with animal-origin tissue, and active participation in daily production activities.

Key Responsibilities :

• Provide quality engineering support for manufacturing, sustaining, and new product introduction.
• Participate in daily manufacturing tier meetings to support production and address quality-related concerns.
• Be present in controlled environment areas / clean rooms to monitor processes, support investigations, and ensure compliance with quality standards.
• Work with tissue from animal origin (porcine and bovine) in accordance with safety and regulatory requirements.
• Investigate product non-conformances and implement corrective and preventive actions (CAPA).
• Lead or participate in process validation activities (IQ / OQ / PQ).
• Ensure compliance with FDA QSR, ISO 13485, and other applicable regulations.
• Review and approve process and product changes.
• Analyze data, conduct risk assessments, and support root cause analysis.
• Lead or support internal and external audits.
• Participate in the development and review of quality documentation (procedures, protocols, reports).

Requirement :

Minimum Requirements :

Bachelor's degree in Engineering, Science, or related technical field.

4+ years of experience in Quality Engineering or a related field in the medical device or regulated industry.

Experience with Nonconformance material reports, CAPAs, and FMEA.

Able to work with Bovine and Porcine tissue.

Working knowledge of FDA regulations and ISO 13485.

Preferred Qualifications :

Experience with CAPA, risk management (FMEA), and process validation.

ASQ certification (CQE, CQA) a plus.

Strong communication and teamwork skills.

Experience with statistical analysis and data interpretation.

HM's Top Needs :

1. Experience with Nonconformance material reports, CAPAs, and FMEA.

2. 4+ years of experience in Quality Engineering or a related field in the medical device or regulated industry.

3. Work in a team environment and Cross collaboration with multiple functional groups

Education Required :

Years' Experience Required :

Benefits : Benefits

Full-time employees (working an average of 30 hours or more) are eligible to select from different benefits packages Packages may include medical, dental, and vision benefits, a 401(k) retirement savings plan with employer match (available after 1 year of employment), commuter benefits, employee discount and referral programs, and life and supplemental income insurance Paid sick leave is provided in accordance with applicable state and local laws.

Compensation

Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience, as well as the benefits package you select.

Work Authorization

ATR International, Inc cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar) Candidates must have valid U.S work authorization.

ATR International, Inc is an equal opportunity employer We celebrate diversity and are committed to creating an inclusive environment for all employees.