Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.

JOB DESCRIPTION

Job Title:        New Product Introduction (NPI) / Validation Quality Engineer         

Department:   Quality

Reports to:     Quality Manager  

Overview

The NPI Validation Quality Engineer is a key member of the Quality product development team charged with the introduction and validation of new product manufacturing processes for commercialization.

Responsibilities

  • Participates in new product/technology development and leads the Process Validation quality activities as part of an overall project team.
  • Develops and executes required validations in line with regulatory standards to include equipment, process and product validations.
  • Executes the project process plans, protocols and generates reports for new product development / design transfer projects as well as process changes.
  • Partner with R&D, DA, PE, QEs to ensure that the transition of products through development and manufacturing scale up are smooth, timely and cost effective.
  • Defines and implements Quality standards and specifications and helps to ensure that Regulatory requirements are met. Continually seeks to drive improvements in product and process quality.
  • Ensures appropriate process monitoring / controls are in place to maintain an effective validated process.
  • Summarizes, analyses and in conjunction with the team draws conclusions and makes appropriate decisions from test results and other process related findings.
  • Support production quality activities for initial commercialization phase of the NPI.
  • Conducts root cause analysis and implements corrective action in a timely manner.
  • Promotes compliance and excellence within the company to customer requirements and the applicable regulatory standards.
  • Conducts audits, including closing out audit findings and creating and determining proper corrective and preventative action.
  • Creates and maintains company quality documentation.

Qualifications

  • An Engineering, Quality Assurance or equivalent science Degree (or equivalent experience).
  • A minimum of 3 years post qualification experience in a quality function with proven validation / NPI experience within a Medical Device or regulated environment.

Competencies and Attributes

  • Strong working knowledge of equipment and process validation within the medical device industry.
  • Knowledge of product development within the medical device industry is desirable.
  • Working knowledge of the regulatory environment in which the business operates including FDA & European Regulatory Validation requirements.
  • Ability to lead and support quality validation activities on multiple projects simultaneously.
  • Strong technical writing and verbal communication skills.
  • In addition, the ideal candidate will have/be:
  • A good team player who works effectively both on their own and with peers from cross functional team members.
  • Strong interpersonal / communication skills, with ability to influence his/her peers and place quality at the forefront of everyone’s daily agenda.
  • An analytical approach to problem solving.
  • Computer System Validation (CSV) experience would be beneficial but not required.
  • Creative, continually learning and challenging the norm.
  • A self-starter who applies his/her own initiative in most situations.
  • Capacity to make sound judgements while learning from mistakes.
  • Attention to detail while maintaining awareness of longer-term objectives.
  • Displays the highest levels of integrity.
  • Capacity to maintain the highest levels of confidentiality internally and externally.

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