My leading MNC medical device manufacturing client have an excellent opportunity for an experienced Design Assurance Engineer to join their team on a Permanent basis.
You will fulfill the quality assurance responsibilities of the company’s new product development and post market (commercial product) support, including:
- Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality.
- Understanding and complying to quality, business, health & safety systems and market/legal regulations governing the quality systems.
- Removing or mitigating against risks associated with the design, use and manufacture of devices.
- Ensuring commitment to training requirements and understanding and complying with all regulations governing your work.
- You will complete work assignments under limited supervision/guidance.
- Interface with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input.
- You will be familiar with requirements and procedures that govern medical device Design Control, Risk Management and Post Market Surveillance.
- Identify and resolve complex exceptions to work assignments.
- Seek to support improvements in product and process quality.
- Build Quality into all aspects of work by maintaining compliance to all quality requirements.
- Posess excellent interpersonal and communication skills with good leadership abilities.
- Provides both quality and technical input to ongoing product development and post market commercial product activities.
- Experienced in post market (complaints) support, risk management, design and process change, standards compliance (to regulatory requirements).
- Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.
- Excellent analytical and problem solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.
- Is an active team member completing quality deliverables associated with new product development and post market (commercial product) support.
- Coaches others in areas of expertise. Gives technical guidance to junior team members. Uses opportunities in project assignments to develop self & others.
- Is a fully motivated team member - achieves and demonstrates best practices in line with set objectives.
- Is willing to implement changes within the project/department practices and supports a culture of challenging the status quo to create best in class.
- Level 8 (240 credits) in a STEM discipline with a minimum of 3-4 years’ experience in a similar role.
- Good technical capabilities, communication skills, teamwork abilities and initiative.
- Proven ability to work well as part of a team & on own with minimum supervision
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