Sr Quality Engineer

Top Tool Company; Brooklyn Park (MN); On-site; USD 95,000 - 110,000; Full time

Job summary

Ein etabliertes Unternehmen im Bereich medizinische Geräte sucht einen Senior Quality Engineer, der Qualitätssysteme und -praktiken entwickelt und aufrechterhält. In dieser spannenden Rolle werden Sie für die Unterstützung der Produktentwicklung und die Einhaltung von Vorschriften verantwortlich sein. Sie werden eng mit verschiedenen Teams zusammenarbeiten, um kontinuierliche Verbesserungen zu fördern und sicherzustellen, dass alle Produkte den höchsten Qualitätsstandards entsprechen. Wenn Sie eine Leidenschaft für Qualität und eine proaktive Einstellung haben, könnte dies die perfekte Gelegenheit für Sie sein, Teil eines innovativen und respektierten Unternehmens zu werden.

Benefits

Gesundheitsversorgung

Zahnversicherung

401(k) mit Unternehmensbeitrag

Fortbildung und Karriereentwicklung

Bezahlte Freizeit

Qualifications

• 5+ Jahre Erfahrung in der Qualitätsingenieurwesen.
• Fluency in computer systems for data analysis.

Responsibilities

• Entwicklung und Pflege von Qualitätssystemen und Verfahren.
• Bereitstellung von Qualitätssupport für Produktentwicklung und Fertigung.

Skills

Qualitätsingenieur

Datenanalyse

Verbal Kommunikation

Prozessverbesserung

Projektmanagement

Education

Bachelor in einem STEM-Fach

Tools

Microsoft Office

Job description

Current job opportunities are posted here as they become available.

Please note - Cirtec is not able to consider candidates who currently have or will need Visa Sponsorship.

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary:

The Senior Quality Engineer will develop, establish, and maintain quality engineering methodologies, systems and practices which meet customer and regulatory requirements. This role will be focused on providing quality engineering support to the new product development process, operations/production, and quality systems. This individual will also serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support site and corporate quality goals and priorities.

Key Responsibilities:

• Provide Quality Engineering support for engineering product development, or sustained manufacturing.
• Provide Quality Project Management support as needed for product transfers from development to validation to production.
• Verification/Validation System Owner responsible for the development and management of the verification/validation master plan along with the verification/validation determination.
• Develop and maintain Standard Operating Procedures.
• Develop and maintain project Quality Plans for assigned projects.
• Develop protocols, perform statistical analyses, and write reports for validations and formal product/process development, which requires quality-engineering involvement.
• Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.
• Provide Quality Engineering support for engineering/manufacturing.
• CAPA (Corrective and Preventative Action) system owner or support responsible for the support of the corrective action system and procedures.
• Interact with customers and suppliers to resolve CAPA and complaint investigations.
• Provide Quality Support for the disposition of material via NCRs.
• Support supplier quality activities including vendor approval and maintaining and assessing vendor performance data (i.e. SCAR/on time).
• Review and document procedure changes for quality requirements and compliance with the quality system.
• Develop quality systems and procedures as needed.
• Audit support for third party audits, customer audits and internal audits.
• Support the implementation of continuous improvement initiatives.
• Develop and maintain production quality control plans.
• Initiate and maintain SPC (Statistical Process Control) for production processes.
• Lead or support FMEA (Failure Modes & Effects Analysis), and DOE (Design of Experiment) as applicable.

Must Have:

• A Bachelor’s degree in a STEM related field.
• 5+ years of experience in quality engineering
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes.
• Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
• Must possess excellent verbal communication, organizational and management skills.
• Must be able to read, write and speak fluent English.
• Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
• Must be able to analyze and process information; promote Process Improvement, Developing Standards, Managing

Good to have:

Competitive market salary from $95000 to 110000 depending on qualifications and experience.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec’s goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.