With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Title: Quality Control Supervisor
Location: Getinge Head Office, Derby
Getinge UKI are seeking a methodical and due-diligent Quality Control Supervisor. In this exciting role, you’ll take ownership of the supervision of all aspects and functions of the Quality Control Lab to support the manufacture and release of regulated products into global markets in accordance with their registered specifications. Additionally, as part of the wider Quality team, this role will be responsible for taking the lead on investigations and be a champion for good manufacturing practice.
Key duties and responsibilites:
Supervise, be an escalation point for, and perform as necessary, the following daily Quality Control Activities:
1. QC testing for raw materials, in process goods, and finished products in accordance with defined procedures.
2. Issuance of batch sheets, batch labels, and product labels in accordance with operational requirements.
3. Generation of COAs and other batch related documentation.
4. Input of required information into the local ERP system, ensuring data integrity, including batch yield information and the adjustment of any production losses.
5. Finished product batch release activities.
6. Management of label stores.
7. Retained samples are stored and controlled appropriately.
Conduct and ensure compliance of the following:
8. Lab equipment is maintained and calibrated according to approved procedures.
9. That QC documentation, methods, procedures, protocols, and reports are effective, up to date and trained out. Support validation of analytical methods.
10. Archiving of batch records, ensuring data integrity and data review as and when necessary.
11. Reporting on batch non-conformances and out of spec results, conduct investigations in the lab and factory, including investigatory testing, to determine root causes and implement effective corrective and preventative actions, maintain good documentation and log as appropriate.
12. Control and impose production holds as necessary relating to Quality issues.
13. Established KPIs are reported on, and data analysis is performed as necessary to identify trends in test results, including first time pass rates
14. Ensure that stock of QC lab consumables, reagents and standard samples are ordered and replenished in a timely manner.
15. Present QC Operation and related data during Competent Authority, Notified Body, Internal and other audits as well as local meetings.
16. Provide SME support to the Operations teams in the factory to help seamlessly resolve issues and continue efficient production.
Lead and Support in the following other business critical areas:
17. Coordination of calibration activities across the organization, keeping the business tracker up to date and coordinating with equipment owners to ensure continued compliance
18. Control non-conforming material by administering appropriate labelling and records of quarantined stock to support disposition decision making
19. Supervise rework activities, where necessary, ensuring appropriate instructions, training, and documentation is provided to operators to ensure compliant rework and release of reworked goods.
20. Lead on process validation activities within the lab and factory, acting as an input into new processes and working with subject matter experts to ensure processes are validated for consistent outcomes.
Who you are:
At Getinge, we are looking for passionate individuals, who are agile, resilient, take responsibility for their development and focus on achieving excellence. They never compromise on quality and always act responsibly remembering that our customers always come first. They enjoy collaboration and working in diverse and international teams and embrace the future.
If you love change, we can make sure that you stay that way!
Knowledge, Skills and Experience:
21. Relevant scientific degree or equivalent in a related discipline is highly advantageous but not essential
22. Minimum 1 years’ experience in a regulated industry performing analytical chemical testing and general product/process quality control is preferred.
23. Knowledge of medical device quality related frameworks such as ISO 13485, Medical Device Regulation, 21 CFR part 820 is desirable although consideration would be given to candidates with similar experience in chemical, pharmaceutical, food, cosmetic, automotive industries with translatable skills.
24. Strong IT skills
Personal qualities:
25. Ability to work in a fast-paced environment with strict deadlines.
26. Great written and verbal communication skills as you will need to engage positively with different stakeholders across the business.
27. Methodical thinker that can analyse and evaluate root causes of issues.
28. Takes pride in generating detailed, high-quality documentation that is engaging and audit ready.
29. Accountability - provide clear and accurate data regarding product and process measurables.
30. Demonstrate good judgement and decision making that is required for effective problem solving.
31. Enthusiasm to drive continuous improvement.
32. Demonstrable leadership qualities and ability to bring others along to perform functional fast-paced tasks.
What we offer:
We offer a competitive compensation and benefits package, to ensure we support your well-being and goals. We understand that a healthy work-life balance is important, so we offer a flexible approach to working patterns as well as a range of enhanced family friendly policies.
Along with a competitive salary, we offer private healthcare, shopping discounts through Perkbox, and an Employee Assistance Programme. We have achieved the Better Health at Work Scheme Gold Award, through providing a range of resources, meetings, activities and training to employees to support their physical and mental health and wellbeing.
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.