Sr. Quality Engineer
QA/RA | Minneapolis, MN | Full Time
The Sr. Quality Engineer helps to direct quality assurance efforts to ensure that the company’s products conform to quality and regulatory standards, establishes and maintains quality assurance procedures and controls, and manages the microbiological procedures (sterilization, bioburden, residuals & environmental monitoring). The Sr. Quality Engineer is responsible for assisting with the Corrective and Preventive Action System (CAPA), Complaint System, Material Review Board (MRB) System, Internal Audit System and Management Review System. Provides a key role in assuring organizational compliance to the defined Urologix quality system, FDA QSR/GMP regulations, ISO 13485 quality system standards and the Medical Device Directive (MDD) with regard to product development and manufacturing.
Typically requires technical degree and a minimum of five years Quality/Regulatory or related work experience. Previous experience in a medical manufacturing environment is required. A bachelor degree in Science or Engineering field is required. Must have the ability to review and evaluate scientific and technical data as it pertains to product and product testing.
- Review and approve product qualification / validation strategies and testing, as required.
- Perform activities associated with supplier qualification and evaluation.
- Perform quality assurance activities and provide guidance to support the Urologix New Product and Continuous improvement projects.
- Conduct GMP/ISO/MDD oversight activities that include internal quality system audits, quality system management reviews and facilitating external regulatory audits.
- In the absence of the Director of Regulatory & Quality, serve as the Management Representative during external regulatory inspection audits (FDA, Notified Body, etc).
- Conduct technical and statistical investigations concerning quality problems.
- Manage the system for handling and reporting customer complaints.
- Manage the system for handling Corrective and Preventive Actions.
- Manage the system for handling MRB and NCR.
- Manage and review Calibrations and PM’s.
- Manage and review CEA operations.
- Provide input and guidance on establishing visual, dimensional and performance requirements for inspection of components, inprocess assemblies and finished products.
- Provide input and guidance on determiningvalid statistical sample quantities associated with component and product evaluations.
- Develop and document test plan protocols, standard operating procedures, specifications and test procedures.
- Document verification and validation findings in technical reports.
- Provide validation support to Urologix sterilization process (es). Conduct and document activities to assure adequate sterilization of all products produced by Urologix.
- Manage and implement quality software procedure and updates.
- Train Urologix employees in quality functions and regulations (i.e. MDD, ISO 13485:2003, FDA QSR / GMP).
- This position may assist with the preparation and submission of regulatory and legal documents associated with new product approvals, changes to existing products, and any legal activities.
- Adhere to and support safety standards, policies and practices.
- Other assignments as requested.