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Cypress HCM

Senior Quality Engineer

Cypress HCM, Minneapolis, Minnesota, United States, 55400

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Sr. Technical Recruiter | Talent Acquisition | Medical Device, Biotech, Life Sciences, Engineering, Regulated, IT Industries We are seeking a detail-oriented and collaborative Sr. Quality Engineer to support the design, development, and commercialization of transcatheter mitral heart valve technologies. This role ensures compliance with global regulatory and quality requirements (FDA QSR, ISO 13485, ISO 5840, and EU MDR) and leads quality assurance efforts across manufacturing processes.

The ideal candidate has hands-on experience in process validation, process optimization, and manufacturing for Class III medical devices.

Base pay range $90,000.00/yr - $130,000.00/yr

Responsibilities:

Lead and execute process validation activities (IQ/OQ/PQ) for new and existing manufacturing processes.

Oversee software validation for manufacturing and quality systems, including protocol creation, testing, and documentation.

Develop and implement quality assurance policies and procedures in compliance with ISO 13485:2016.

Conduct and report internal audits per ISO 13485:2016 and company audit schedules.

Support nonconformance investigations (NCMRs), CAPA activities, and root cause analyses.

Lead corrective and preventive action initiatives to resolve quality issues.

Collaborate cross-functionally to enhance process efficiency and product quality.

Analyze quality data and metrics to identify trends and improvement opportunities.

Review and approve process changes to ensure regulatory compliance.

Oversee cleanroom qualification and environmental monitoring programs per ISO 14644 and GMP standards.

Promote a culture of collaboration, accountability, and continuous improvement.

Provide clear direction and structure to team members and cross-functional partners.

Apply a methodical, data-driven approach to problem-solving.

Work independently in a fast-paced, dynamic environment.

Qualifications:

Bachelor’s degree in Engineering (Manufacturing, Mechanical, or Industrial preferred).

7+ years of experience in manufacturing quality engineering.

Certified Internal Auditor (ISO 13485:2016) preferred.

Experience with lean manufacturing and Six Sigma methodologies.

Experience supporting PMA and CE Mark submissions for Class III medical devices.

Proven knowledge of design controls, risk management, DHF documentation, and process/test method validation.

Strong knowledge of QMS and statistical process control.

Proficiency with quality management and data analysis tools.

Excellent verbal and written communication skills.

Skilled in technical writing and report preparation.

Strong interpersonal and teamwork abilities.

Deep understanding of ISO 13485, FDA QSR, and new product development processes.

Able to manage multiple projects and maintain confidentiality.

Pay Range: $90-130k

Seniority level Mid-Senior level

Employment type Full-time

Job function Engineering and Quality Assurance

Industries Medical Equipment Manufacturing

Benefits Medical insurance

Vision insurance

401(k)

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