This new role is part of a new function and as such we're specifically looking for someone with start-up > SME transition experience, with broad, dynamic skill-set.
The Quality Engineer is responsible for assuring quality standards and regulatory compliance are consistent with Company’s Policies, Government Regulations, International Standards and Standards of the Medical Device Industry, and IVD. You will be responsible for supporting new product development and product maintenance through the use of Quality Engineering skills. You will also be responsible for Design Verification and Validation and Process Validation plans.
£30,000 - £50,000
Your Key Responsibilities:
- Provide Quality engineering support to all assigned projects, manufacturing projects and suppliers.
- Function as a Quality Representative on Design/Development and Manufacturing Development project teams.
- Assess current operations for quality and compliance.
- Develop & implement quality improvement programs.
- Ensure Design Control Elements are satisfied.
- Ensure that project development standards are followed.
- Assist/conduct Failure Investigations and problem solving sessions (CAPA).
EXPERIENCE, KNOWLEDGE & SKILLS
- Good understanding of Statistical Methods for Quality Assurance (Capability, DOE, etc)
- General working knowledge of the 6 sigma process methodology
- Thorough understanding of industry regulations and practices: QSR/cGMP, ISO QM standards, ISO 13485, 21 CFR 820, IVD regulations. DFx.
- Excellent problem solving and analytical skills
- Ability to handle multiple projects simultaneously in an unsupervised environment
- Ability to thoroughly evaluate, clearly understand and communicate all aspects of assigned project.
- Quality Engineering experience or relevant industry experience (Healthcare/ Pharmaceutical). IVD would be a plus.
We look forward to hearing from you and introducing you to Osler, thank you for taking the time to consider us and make your application.
Join us and build a better future.