Job Scope

As a member of the Product Quality Assurance Engineering team, this role will serve as a subject matter expert and go-to authority, regarding best Quality practices and ensuring all Product Quality related activities are performed in a complaint manner to support business objectives. In addition, as a member of the Product Quality Assurance Engineering team, this role will be responsible for serving as an internal consultant on the following activities: Process Controls, Equipment and Process Validation, Nonconforming Product, Risk Management, new Product Development, CAPA, Design/Change Control and Statistical Methods.

Job Responsibilities and Duties

• Provide QA representation, support and advisement within cross-functional teams relating to (but not limited to):
  • Non-conforming product
  • CAPA
  • Process and Material Validation
  • Change Management
  • Design Control and new Product Development
  • Supplier quality and manufacturing issues
  • Corporate and local quality plans/projects
  • Continual improvement of the QMS and product quality
  • Operational Excellence and Lean projects
  • Risk Management
  • Support the NCR (Non-Conformance) system - review and approve issues, make recommendations, monitor efficacy through key NCR process metrics and help to support and drive the success of metrics
  • Ensure procedures are established and accurate to support new Product Development, Product Design Transfer and manufacturing process
  • Review design and development processes, ensuring appropriate documentation is established in accordance with the Design Control procedures
  • Review manufacturing and product development validation activities to ensure that they are well established, risk based and compliant with applicable regulations.
  • Review, approve and provide recommendations on Change Requests.
  • Gather, analyze and report data reflecting status of product and process and provide recommendations to improve such activities
  • Use statistical tools to analyze data to make acceptance decisions and improve processes and product
  • Review and approve equipment and process validation protocols/reports
  • Recommend methods, techniques and principles to ensure compliance, safety, efficacy and efficiency
  • Work with manufacturing and supply chain to resolve supply issues of critical components, sub systems and finished product to ensure that all changes are appropriately validated
  • Initiate, investigate, own, drive and/or participate in NC and CAPA issues as needed
  • Analyze and translate technical data
  • Participate on internal audit team and support external audits
  • Perform other duties as assigned.

Education, Experience and Qualifications

• Bachelor's Degree in Engineering, Life Sciences or related field, or equivalent experience required or

• 3+ Years years of quality engineer experience in medical device or other regulated industry
  • FDA QSR and ISO 13485, 9001 & 14971 and MDSAP Compliance
  • CAPA and Root Cause Analysis
  • Quality Auditing (both in performing internal audits and participating in external audits)
  • Document and Change Control
  • Nonconformance Process
  • Design and New Product Development
  • Process Validation methodology
  • Risk Management and usage of PFMEA templates
  • Statistical methods (process capability, hypothesis testing, regression/correlation, SPC, DOE)
  • Computer skills and software knowledge - MS Word, PPT and Excel
  • Immunochemistry/immunoassay
  • Six Sigma methodology
  • IVDR or MDR
  • Software Validation and Data Integrity
  • Working knowledge of statistical methods
  • Usage of a QMS software system
  required

What we offer

The hiring range for this position is $74,800 - $93,400 annually. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.

Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.