Quality Assurance (QA) Engineer
- Reference: Quality Assurance (QA) Engineer
- Closing Date: 01/04/2023
- Type: General Application
Job Title: Quality Assurance (QA) Engineer
Reporting To: Quality Assurance and Regulatory Affairs (QARA) Manager
Direct Reports: N/A
Working Hours: Standard, Non-Shift, Monday to Friday
Start Date: Jan 2023
We Are Welland
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 Ltd®, established in 1988 is part of the CliniMed® Group, and has over 250 colleagues committed to enhancing people’s lives.
We collaborate by embracing differing perspectives to make better decisions and continuously improve.
We pride ourselves on our innovative spirit by creating novel solutions within the workplace and in stoma care.
We commit to empower and respect each other, ethically, honestly and with fairness.
We are passionate about recognising talent and providing an equal and supportive workspace for all to thrive.
We commit to setting the highest standard of quality in everything we do to enhance people’s lives every day.
Summary Of The Role:
This is an excellent opportunity to join a rapidly growing global medical device manufacturer, with our headquarters based in Manor Royal, Crawley, in our purpose built premises.
We are looking for someone to join our Quality Assurance and Regulatory Affairs (QARA) team to help support them in maintaining company Regulatory Compliance against ISO 13485, MDD 93/42/EEC and MDR EU/2017/745.
You will have a drive for maintaining procedures and regulations, work well as part of a team, along with a passion to enhance people’s lives.
Main Duties and Responsibilities
As part of your role at Welland, you will be fully integrated within the QARA team, with focus and ability to:
- Ensure the QMS is adhered to and that ISO standard requirements are met and maintained
- Assist in the improvements of QMS against ISO 13485
- Calibrate Production Equipment as necessary in a timely manner and maintain the calibrationdatabase Maintain and report on quality metrics
- Manage or assist with customer complaints and complaint reporting
- Assist in post market surveillance (PMS) and post market clinical follow up (PMCF) activities
- Conduct Incoming Inspection sampling and analysis of raw materials
- Support training to site staff on Quality System procedures as required
- Assist with Corrective and Preventive Actions (CAPAs) and support CAPA teams as necessaryAssisting the business in closing CAPA and Non – Conformances
- Providing QA support and approval of CAPA and Non-Conformances
- Undertaking 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
- Work with manufacturing team (Operations, Engineering and Planning Departments) in drivingthrough the focus, teamwork and support required to ensure the delivery of all keymanufacturing KPl’s.
- Contribute to Lean Manufacturing Six Sigma Projects and communicate progress to ClManagement with regards to key KPls
- Support Manufacturing to ensure quality issues are dealt with and closed out in a timely manner
A degree of flexibility is needed and the job holder may be required to perform work not specifically referred to above and which will be appropriate to the level of the role.
Our colleagues are at the heart of what we do. Our passion for our colleagues wellbeing is reflected in our values and we offer (and not limited to) the following perks to all our colleagues:
- Competitive company pension, that increases with length of service
- Health benefits
- Life insurance
- 25 holiday days plus statutory bank holidays
- Company Christmas shut down
- Discount at a number of high street retailers and other local discounts
- Complementarity company day
- Free onsite parking (including electric vehicle charging)
- Cycle to work scheme
This is a description of the job as it exists at present. All Job Descriptions are liable to variation in order to reflect any future role/obligations change and employee development.
For more information, please contact our recruitment team at firstname.lastname@example.org. A covering letter and CV are required with all applications.