Quality Engineer

• Partner with R&D and Process Engineers to ensure that the transition of products through R&D and sister sites, product approval and manufacturing scale up are smooth, timely and cost effective.
• Promotes compliance and excellence within the company to customer requirements and the applicable regulatory standards.
• Participates in new product/technology development and supports the QA activities as part of an overall project team.
• Executes the project design plans, protocols and generates reports for new product development projects as well as design/process changes.
• Summarizes, analyses and in conjunction with the team draws conclusions and makes appropriate decisions from test results and other process related findings.
• 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.
• Develops and executes required validations in line with regulatory standards to include equipment, process and product validations.
• Conducts root cause analysis and implements corrective action in a timely manner.
• Conducts audits, including closing out audit findings and creating and determining proper corrective and preventative action.
• Creates and maintains company quality documentation.
• Deals with suppliers and ensures their quality standards are in line with company standards.
• Managing and investigating customer complaints including carrying out failure mode analysis and implementing required CAPAs relating to complaints where required.
• Provides manufacturing line support and provide Quality expertise in relation to Manufacturing issues and product disposition.

• An Engineering or Quality Assurance Degree or equivalent experience.
• A minimum of 3 years post qualification experience as a Quality Assurance Engineer within a Medical Device or regulated environment.

• Demonstrable detailed working knowledge of the medical device industry.
• An analytical approach to problem solving.
• Is creative, continually learning and exploring new ideas.
• A self starter that applies their own initiative in most situations.
• A good team player, who works well in a small team environment, must be able to work effectively with peers in other Departments.
• A good communicator who can easily convey his/her ideas and requirements across all levels in the organisation.
• Capacity to make sound judgements while learning from mistakes.
• Detailed knowledge of the regulatory environment in which the business operates including FDA, European, Canadian, Japanese and other International Regulatory requirements.
• Attention to detail while maintaining awareness of longer-term objectives.
• Strong interpersonal skills, a demonstrated ability to influence his/her peers and place quality at the forefront of everyone's daily agenda.
• Displays the highest levels of integrity.
• Capacity to maintain the highest levels of confidentiality internally and externally.
• Ability to stay connected to multiple projects simultaneously.

• Competitive Salary Package
• 4 day working week
• Medical Insurance
• Defined Contribution Pension with employer match
• Bonus program
• Life assurance cover
• Recognition Awards
• Career advancement opportunities

Surmodics