Quality Assurance Specialist
Posted: August 10, 2022
Department: Quality and Regulatory
Job ID: JP-10002
Employment Type: Full-Time
Location: Eden Prairie, MN
Job Posting Details:
Walkasins by RxFunction is an innovative and exciting new medical device for individuals struggling with balance and mobility due to sensory peripheral neuropathy. At RxFunction, we are passionate about enhancing our patients’ quality of life with Walkasins by restoring their balance and confidence in
walking. We foster a culture of innovation and diversity and offer an environment where people can do their best work.
We strive to hire the best and brightest and offer a fast-paced, collaborative environment where team members are valued on every level and can make an impact.
RxFunction is an equal opportunity employer, and all qualified applicants will receive consideration for employment.
As the Quality Assurance Specialist, this position is mainly responsible for monitoring, inspecting and proposing measures to correct or improve the organization’s final products in order to meet established quality standards. The QA Specialist also directly supports the development and maintenance of a quality management system (QMS) that complies with all relevant regulations and applicable standards.
As the Quality Assurance Specialist, this position is responsible for and has authority that includes:
- Preparing and implementing quality system policies and quality assurance procedures.
- Maintaining the equipment calibration and maintenance program.
- Performing first article and routine incoming and production inspections and quality tests.
- Placing nonconforming product on quality hold.
- Planning and conducting internal and supplier audits, and effectively reporting findings.
- Conducting and documenting failure investigations for products and processes.
- Assisting with the handling and investigation of customer complaints and corrective / preventive actions (CAPA).
- Supporting Operations by identifying and resolving workflow and production issues.
- Supporting Engineering by executing test and validation protocols.
- Ensuring that standards and safety regulations are observed.
- Creating and presenting training materials; ensuring fulfillment of all required training.
- Making recommendations for product and process improvements.
- Working with cross-functional teams to help improve the business.
- Other duties as assigned.
- Two-year technical degree or certificate required; a four-year degree is preferred.
- Three years’ experience in a quality assurance role(s); medical device experience is preferred.
- Solid knowledge of relevant FDA regulations and quality management system standards, including 21 CFR 820 and ISO 13485:2016.
- Working knowledge of quality assurance tools, methods and concepts.
- Ability to interpret dimensional requirements on drawings and specifications.
- Excellent communication skills, both verbal and written.
- Good data collection and analysis skills.
- Intermediate computer skills, e.g., MS Office.
- Strong attention to detail and data integrity.
- ASQ Certified Quality Engineer, Auditor or Process Analyst (CQE, CQA, CQPA).
- Completion of an accredited 3-day ISO 13485:2016 auditor training program.
- The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to use a computer and communicate with others.
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