About the role
AI summarisedThis is a mid-level Quality Engineer role in a regulated medical device manufacturing environment. The position involves providing quality engineering support throughout the product lifecycle, driving risk management, ensuring compliance with FDA and ISO standards, and leading continuous improvement activities.
BiotechFull-timeGeneral
Key Responsibilities
- Provide quality engineering support throughout the product life cycle.
- Provide support to engineering and manufacturing functions. Assist teams in determining issue resolutions using a risk-based approach
- Provide support to moderate scope activities where analysis of situations or data requires a review of a variety of factors
- Applies problem-solving techniques to define and resolve routine issues of moderate scope
- Drive activities in prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
- Work with project teams to ensure understanding of and compliance with regulations, procedures, and requirements. Provide training, guidance and interpretation as needed.
- Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
- Provide consultation to end users and process owners with regard to data collection, analysis and creation of reports.
- Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making
- Coordinate issue resolution using a risk-based approach
- Identify areas and opportunities to improve quality system processes
- Ensure product development and validation programs meet requirements of FDA and ISO
Requirements
- Quality related experience preferred
- Highly effective communication, facilitation, coaching, and negotiation skills
- Adaptable to fast-paced, dynamic work environment with shifting demands
- Ability to identify, assess, resolve and where needed, escalate risks
- Demonstrated ability to accomplish goals while working across departments is required.
- Bachelor's degree in Engineering, Science, or other related field required (or equivalent combination of education and experience).
- 3+ years' experience in quality assurance field, in a regulated environment.
- Experience applying quality regulation standards (e.g 21CFR820, ISO 13485, ISO 14971, IVDD)
- Practical experience in risk management, validation, change control etc.
- Experience with CAPA and failure investigation tools and techniques
- Applied experience with quality and statistical analysis tools (e.g. SPC, 6 Sigma, Risk Analysis, FMEA, DOE, and trend analysis.