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- Tasks: Ensure quality standards are met and improve processes in a collaborative environment.
- Company: Welland Medical creates innovative products to enhance the lives of people with stomas globally.
- Benefits: Join a passionate team with opportunities for growth and development in a supportive culture.
- Why this job: Make a real difference in people's lives while working with cutting-edge technology and a dedicated team.
- Qualifications: No specific qualifications mentioned; enthusiasm and a willingness to learn are key.
- Other info: Be part of a company with a strong ethical commitment and a focus on quality and safety.
The predicted salary is between 36000 - 60000 £ per year.
Welland Medical brings to market the best and most innovative products that enhance the lives of people living with a stoma across the world. Investing in the most talented people, collaborating to create world-class, ground-breaking products and services devoted to improving peoples’ lives. We are passionate about making a difference in the world. Our reputation is based on a tradition of improvement, ethical leadership, and total commitment to quality and safety. Welland Medical, established in 1988, is part of the CliniMed Group, and has over 240 colleagues committed to enhancing people’s lives.
Main Duties and Responsibilities
- Ensure the QMS is adhered to and that ISO standard requirements are met and maintained.
- Assist in the improvements of QMS against ISO 13485.
- Work with manufacturing teams (Operations, Engineering and Planning Departments) in driving through the focus, teamwork and support required to ensure delivery of all key manufacturing KPI’s.
- Maintain and report on quality metrics.
- Support training to site staff on Quality System procedures as required.
- Providing QA support and approval of CAPA and Non-Conformances.
- Assist with Corrective and Preventive Actions (CAPAs) and support CAPA teams as necessary.
- Assisting the business in closing CAPA and Non-Conformances.
- Support Manufacturing to ensure quality issues are dealt with and closed out in a timely manner.
- Manage or assist with customer complaints and complaint reporting.
- Conduct Incoming Inspection sampling and analysis of raw materials.
- Assist in post market surveillance (PMS) and post market clinical follow up (PMCF) activities.
- Calibrate Production Equipment as necessary in a timely manner and maintain the calibration database.
- Undertake Quality Audits (Internal, Supplier) against ISO 13485 / 9001.
- Responsible for logging, monitoring, and closing audit actions, Internal, and Supplier.
- Assist with new material, Equipment, CSV, and Process validation as necessary.
- Contribute to Lean Manufacturing Six Sigma Projects and communicate progress to CI Management with regards to key KPIs.
For more information please contact our recruitment team.
QA Engineer employer: Welland Medical Ltd
Contact Detail:
Welland Medical Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Engineer
✨Tip Number 1
Familiarise yourself with ISO 13485 and ISO 9001 standards, as these are crucial for the QA Engineer role. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality management.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in quality assurance. Engaging with them can provide insights into the company culture at Welland Medical and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to quality improvement initiatives in previous roles. Highlighting your experience with CAPA and non-conformance management will show that you're ready to tackle the responsibilities of this position.
✨Tip Number 4
Stay updated on the latest trends and technologies in quality assurance within the medical field. Being knowledgeable about current practices will set you apart and show your enthusiasm for continuous improvement.
We think you need these skills to ace QA Engineer
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the QA Engineer position at Welland Medical. Understand the key responsibilities and required skills, such as knowledge of ISO standards and experience with quality metrics.
Tailor Your CV: Customise your CV to highlight relevant experience and skills that align with the job requirements. Emphasise your familiarity with QMS, ISO 13485, and any previous roles where you contributed to quality assurance or improvement projects.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and how it relates to enhancing people's lives. Mention specific experiences that demonstrate your ability to work collaboratively with manufacturing teams and manage quality issues effectively.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial for a QA Engineer role.
How to prepare for a job interview at Welland Medical Ltd
✨Understand ISO Standards
Familiarise yourself with ISO 13485 and ISO 9001 standards, as these are crucial for the QA Engineer role. Be prepared to discuss how you have applied these standards in previous positions or how you would approach compliance in this new role.
✨Showcase Your Teamwork Skills
Since the role involves working closely with manufacturing teams, highlight your experience in collaborative environments. Share specific examples of how you've successfully worked with cross-functional teams to achieve quality goals.
✨Prepare for Quality Metrics Discussion
Be ready to talk about quality metrics you've monitored or reported on in the past. Discuss how you used these metrics to drive improvements and support decision-making processes within your team.
✨Demonstrate Problem-Solving Abilities
The role requires managing customer complaints and non-conformances. Prepare to share examples of how you've effectively resolved quality issues in the past, including your approach to CAPA and how you ensured timely closure of issues.
