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Quality & Validation Engineer
Quality & Validation Engineer
The Main Purpose of the Role:
This role will undertake both Validation and Quality Engineer duties to ensure that manufactured products meet company and customer quality specifications; they are also responsible for designing inspection sheets and assigning inspection levels and frequencies, troubleshooting Quality issues, and assisting Engineering, Production, and other Departments in maintaining the Quality Systems at Schivo Medical in compliance with ISO13485 and AS9100 requirements.
This involves working very closely with Schivo Medical QCI, Production and Engineering personnel in carrying out scheduled and random checks on product quality during the production process and also finished product tests prior to dispatch to the customer.
- A proven solutions provider that can work in a fast pace environment across multiple projects with a customer focussed approach
- A process thinker with a proven track record for delivering value add to the bottom line through CI initiatives
- An individual of strong character who can challenge the norm in a professional manner, capable of articulating complex solutions to key stakeholders across organisations (internal & external)
- Exceptional technical report writing skills required with a logical flow to his / her approach
- Able to lead environmental monitoring programs for cleanroom activities.
- Can work effectively with minimal guidance.
- Honours (level 8) Degree in Mechanical/Manufacturing/Production Engineering or similar.
- Validation of manufacturing processes and clean room environments.
- Background knowledge in Reg requirements.
- >5 Years’ experience in a production environment.
- >5 years’ experience in quality department.
- >5 Customer Complaints Management experience.
- GMP experience essential.
- ISO 9001-13485 CFR 820 Knowledge essential.
- Understanding of design and the ability to assess concepts with a risk base approach.
- Excellent customer contact, negotiation, and problem resolution skills.
- Able to independently work with quality tools and knowing when to implement them across teams, RC, Brainstorming, 5Why, Fishbone, CAPA, NC, NCMR, 8D, A3, SIPOC, Process Maps, Heat Maps.
Key Duties /Responsibilities:
- Creates concise and accurate on-time technical reports. Clearly communicate results internally and to customers through the use of quality tools and statistical techniques.
- SME for appropriate statistical techniques to monitor process performance (e.g. SPC, Cp, Cpk, R&R analysis, sampling techniques, and other statistical techniques).
- Acts as the customer conduit for all quality related issues, capable of articulating complex technical solutions to customers in a manner that’s easily understood.
- Creates and evaluates metrics to drive tangible quality improvement.
- Evaluate materials, gather and analyse data and determine the root cause of problems using relevant corrective action systems (e.g. CAPA / 8D / A3 Problem Solving).
- Conducting and leading internal audits.
- Managing and ensuring close out of CAPAs.
- Supporting manufacturing on ensuring quality standards and compliance.
- Conduct validation activities in compliance with regulations, company procedures, customer procedures, and EHS requirements.
- Prioritize qualification activities in line with the project schedule.
- Co-ordinate qualification activities with operations and engineering departments.
- Lead internal risk assessments (FMEA).
- Assist with Process Development activities.
- Develop validation documentation (e.g. specifications, plans, protocols, procedures).
- Co-ordinate qualification document review and approval.
- Execute qualification protocols.
- Track and resolve deviations during qualification activities.
- Compile relevant documentation from suppliers, and other departments for inclusion in validation protocols/reports.
- Prepare reports of executed protocols, for review and approval.
- Assist in the development of training material for qualification activities.
- Ensure that any maintenance and Health and Safety problems/issues are reported.
- Maintain company Health and Safety standards including PPE (safety shoes, company uniform, safety glasses etc.).
- Ensure compliance with company procedures at all times.
** This list is not an exhaustive list of duties; you may be required to fulfil other Ad Hoc duties anywhere throughout the company as required.