Sr. Quality Engineer

Sr. Quality Engineer

We are seeking a highly motivated Sr. Quality Engineer to support global quality improvement initiatives across the company's medical device product portfolios. This role will serve as a key Design Quality representative on cross-functional projects focused on quality improvement, cost reduction, operational efficiency, and regulatory compliance.

The ideal candidate will bring strong medical device quality experience, expertise in Design Assurance and Design Controls, and the ability to independently lead multiple projects while collaborating effectively with global stakeholders.

Key Responsibilities

• Serve as the Quality Lead representative on global quality improvement, cost-down, and efficiency projects.
• Review, approve, and support design control documentation, qualification activities, protocols, validation deliverables, and quality processes.
• Ensure products, manufacturing processes, and quality systems remain compliant with applicable regulatory and quality requirements while achieving business objectives.
• Collaborate with engineering, manufacturing, operations, and cross-functional teams to establish and maintain quality standards.
• Develop, modify, implement, and maintain quality standards, protocols, and procedures for product and process quality.
• Support inspection, testing, and evaluation methods to verify product performance and compliance.
• Conduct quality investigations, root cause analysis, and corrective and preventive action activities as required.
• Perform risk-based assessments and statistical analysis to evaluate quality performance and drive continuous improvement.
• Ensure documentation, quality records, and corrective actions meet applicable regulatory and internal requirements.
• Contribute to Lean, Six Sigma, and continuous improvement initiatives to enhance product quality, efficiency, and cost effectiveness.

Minimum Education Required

Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical discipline.

Minimum Experience Required

5-7 years of quality engineering experience within the medical device industry.

Self-driven leadership with the ability to independently manage multiple projects and collaborate across cross-functional teams.

Strong understanding of Design Assurance, Design Controls, and product development processes.

Experience supporting regulated medical device products and quality systems.

Demonstrated ability to work independently, manage multiple priorities, and influence cross-functional stakeholders.

Experience reviewing and approving technical documentation, protocols, and validation deliverables.

Strong problem-solving, communication, and project management skills.

Preferred Qualifications

Experience with Lean Manufacturing, Six Sigma, or continuous improvement methodologies.

Knowledge of FDA, ISO 13485, and other applicable medical device regulatory requirements.

Experience supporting quality initiatives across multiple product lines or global organizations.

Lean Six Sigma Green Belt, Black Belt, or equivalent certification is a plus.

Shift

First (Day)

Number of Openings

1

Public Transportation Accessible

Yes

Veterans Encouraged to Apply

Yes

Physical Required

No

Drug Test Required

Yes

Compensation

$45.00 - $55.00 / Hourly

Postal Code

55432

Job Type

Contract (W2)

Place of Work

On-site

Requisition ID

6770

Job Benefits

Health Insurance, Life Insurance, 401k retirement plan, paid sick time