Quality Engineer

Job Summary

We are seeking a dedicated professional to join our team. This role involves maintaining and updating quality management processes to meet Quality/Regulatory requirements, specifically within the medical device sector. The ideal candidate will collaborate closely with the product team to enhance product and process quality, ensuring compliance with FDA and EUMDR standards.

Responsibilities

• Work with the quality management team to maintain and update quality management processes and activities to meet Quality/Regulatory requirements.
• Collaborate with the product team to maintain and improve product and process quality for FDA & EUMDR Class II medical devices.
• Participate in ISO & EUMDR audits and FDA inspections.
• Responsible for QA-related internal training.
• Support design inputs/outputs, design reviews, verification & validation (V&V), and design transfer to manufacturing.
• Ensure design controls comply with applicable regulations throughout the lifecycle.
• Support risk management activities per ISO 14971, including hazard analysis and risk assessments.
• Support manufacturing process controls, change control, and production quality.
• Investigate nonconformances and support root cause analysis and CAPA activities under the guidance of the Quality Manager.

Qualifications

• BS/BA or advanced degree in a related discipline.
• 3-5 years of experience in Quality Management, preferably with a manufacturer of medical devices including software.
• Strong knowledge of compliance with FDA QMSR, ISO 13485, and EUMDR.
• Successful experience in external audits and inspections.

Benefits
PEAK's benefit offerings available for our associates include medical, dental, vision, Flexible Spending Account (FSA), Dependent Care Savings Account (DCA), and 401K plan. PEAK believes that taking care of our team is essential for success and we are proud to provide benefits that enhance both your well-being and your future. Additionally, our associates may be eligible for Paid Sick Leave as required by Federal, State, or local laws.  

Equal Opportunity Employer (EEO) 
PEAK Technical Staffing is committed to creating a diverse and inclusive environment and is proud to be an Equal Opportunity Employer. PEAK does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status, or any other characteristic protected by applicable law. All employment decisions are made based on qualifications, merit, and business need. We encourage all individuals to apply. 

Americans Disabilities Act (ADA) 
The physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of the position. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. Must be able to perform the essential physical functions of the position, including sitting, standing, walking, stooping, kneeling, and lifting up to 25 pounds, with or without reasonable accommodation. 

Candidate Privacy
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://peaktechnical.com/privacy-policy/ and https://peaktechnical.com/ca-residents-privacy-rights/  

AI Recruiting Disclosure 
We use AI-assisted tools to help review applications and compare your experience to job requirements, but all hiring decisions are made by human recruiters. You may request a human-only process or opt out of automated communication at any time. Required notices and our latest bias audit are available on our website: www.peaktechnical.com/ai-disclosure.