Quality Engineer - Inverness - 12-month Contract - can work 50/50 from site / home
Due to a new product range being launched, our client - a large medical device company, is looking for the services of a Quality Engineer to assist them with looking after their existing product range so they can concentrate in rolling out their new launch. It is a 12-14 month contract and can support a 50/50 factory/home working pattern if the successful candidate is not based in the Highlands area.
Role Profile: The role of the Quality Engineer is to provide technical Quality Engineering leadership to our client's business to ensure the highest levels of product quality, process, and systems integrity to the customer.
Technical Competencies and Responsibilities:-
* Has a planning outlook out to the next quarter
* May lead people, directing small groups in focused day-to-day tasks.
* Translates given tactics and measures into actions, independently.
* May participate in goal setting.
* Leads simple projects within own function. Contributes to cross functional or global projects.
* Proactive. Identifies opportunities for improvements in own area of work.
* Makes decisions based on data. Technically proficient. Escalates issues as appropriate.
* Is recognised as a Subject Matter Expert for a narrow-defined area of responsibility.
* Participates in New Product teams may sit on a project core team.
* Works with business partners to ensure customer needs are met.
* Works to ensure design controls are implemented within new product teams.
* Leads day-to-day support of operations.
* Works with business partners and suppliers to ensure product quality and compliance to quality systems.
* Leads activities such as defect reduction initiatives, quality metric improvements, root cause analysis, problem solving.
* Participates in activities related to transfer of product design into operations
* Uses Plan-Do-Check-Act and other established methods.
* Supports Validation of new and changes to Process and Equipment.
* Understands the breadth of the quality system. monitoring, risk management activities.
* Participates in and may lead improvements to quality systems.
* Trains others in quality systems, tools and objectives.
* Participates in and leads activities within the quality system such as: change control, design control, NC, CAPA, supplier monitoring, risk management activities.
* Integrity based Actions
* Results & Performance Driven
* Sense of urgency
* Prudent Risk Taking
* Collaboration & Teaming
* Degree in relevant discipline or equivalent experience
* Chartered status in relevant discipline
* PeX Green Belt
* ASQ certification
* Quality systems
* Product Knowledge
* Manufacturing knowledge
* Working knowledge of regulatory and compliance environment i.e. ISO 13485:2003; 21 CFR Part 820, ISO 14971 and ISO 15197
* Risk Management tools e.g. FMEA; SRA; DOE
* Working knowledge of failure investigation
* Validation of Processes and Equipment
* Process Excellence
* Process/technical Transfer
* Knowledge of diabetes
* Budgetary control
* Formal Leadership / Management training
* Meeting Management
* Technical Leadership skills
* Quality Acumen
* Data driven decision making
* Time Management
* Ability to train others
* Proactive approach to issue identification and problem resolution
* Verbal communications
* Resilient and ability to work under pressure.
* Trouble shooting and problem-solving skills
* Change Management experience
* Lean experience
* Training / mentoring / coaching of technical staff
* Demonstrated Project Management skills