quality engineer.

　　minneapolis , minnesota

　　posted 2 days ago

　　job details

　　summary

　　$80,000 - $95,000 per year

　　permanent

　　bachelor degree

　　category production occupations

　　referenceAB_4452260

　　job details

　　Join our innovative team! We're seeking a Design Quality Engineer to play a key role in our dynamic environment. Be the driving force behind:

　　Creating and implementing design control deliverables. Leading on-time Design Verification, Validation, and supporting Process Validation. Actively participating in core team and customer-facing meetings. Driving translation of User requirements into measurable Product specifications. Overseeing risk management throughout the device life cycle. Creating accurate test methods and supporting biocompatibility and sterilization qualifications. Analyzing data and ensuring the integrity of the Design History File. Defining and evaluating component specifications. If you are interested, directly below, or send an email directly to [email protected].

　　salary: $80,000 - $95,000 per year

　　shift: First

　　work hours: 8 AM - 4 PM

　　education: Bachelors

　　Responsibilities

　　Own creation and implementation of all design control deliverables.

　　Lead on-time Design Verification, Design Validation, and support Process Validation.

　　Actively participate in core team and customer-facing meetings.

　　Drive meaningful translation of User requirements into discrete, measurable, and verifiable Product requirements.

　　Oversee risk management activities throughout the device life cycle.

　　Create accurate and repeatable test & inspection methods.

　　Support creation and execution of biocompatibility and sterilization qualifications.

　　Analyze data and prepare product test reports.

　　Oversee content of Design History File, ensuring completeness and integrity.

　　Ensure component specifications are properly defined and evaluated, including supplier management activities and external audits.

　　Education/Experience/Skills:

　　BS degree in Engineering, Science, or a technical field with regulated manufacturing experience.

　　Demonstrated use of quality tools and methodologies.

　　strong problem-solving skills.

　　Ability to manage and prioritize multiple tasks with high attention to detail.

　　Proven ability to work independently and in a multi-disciplinary team.

　　Good understanding of ISO 13485 and FDA QSR.

　　ISO 13485 Lead Auditor training and certification.

　　Skills

　　Quality Control

　　Engineering

　　Quality Assurance

　　Qualifications

　　Years of experience: 3 years

　　Experience level: Experienced

　　Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.

　　Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

　　At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

　　Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

　　Applications accepted on ongoing basis until filled.

　　get in touch

　　we are here to help you with your questions.

　　KP

　　kevin pribyl

　　[email protected]