Job Description
We are Hiring
The position holder will be responsible for the quality management system as per ISO 13485: 2016 requirements.
Flexicare is a leading UK manufacturer of medical devices. Backed by over 35 years of experience in design and development, supported by a modern manufacturing facility, Flexicare has built a world class reputation for the supply of consumable medical devices.
Flexicare Lanka (Pvt) Ltd, a fully owned subsidiary of Flexicare Group, U.K. with its state-of-the-art modern manufacturing facility in Bandaragama which is a Board of Investment of Sri Lanka approved project. Flexicare Lanka (Pvt) Ltd is an ISO 13485 and GMP certified company. Flexicare distributes its products over 100 countries worldwide through a network of distributors and its own offices across Europe, the Middle East, India, Far East, USA and Australia.
Eligibility Criteria :
- Bachelor’s degree in Polymer Science, Life Sciences, Pharmacy, Biomedical Engineering, or equivalent.
- 2–5 years of QA experience in a regulated medical device or pharmaceutical manufacturing environment.
- Strong understanding of QMS and regulatory requirements.
- Proficiency with MS Office and QMS software/tools.
- Detail-oriented with good problem-solving abilities.
- Ability to work independently and within cross-functional teams.
- Knowledge of ISO 9001 QMS and microbiology is an added advantage
- Preference will be given to those who reside near Bandaragama area.
“We are an equal opportunity Employer”
Duties & Responsibilities :
- Ensure compliance with ISO 13485 and applicable regulations
- Ensure products are manufactured in compliance with regulatory standards
- Support audits and management reviews.
- Maintain and update SOPs, records, and controlled documents.
- Investigate non-conformities, manage CAPAs, and track effectiveness.
- Assist in supplier evaluations and manage quality issues.
- Maintain training records and ensure QMS awareness across teams.
- Evaluate and document changes to processes, materials, or documents
- Support risk assessments and implementation of mitigation actions.
- Assist in process, equipment, and cleaning validation activities.
- Supervise and mentor junior QA staff, ensuring task delegation and adherence to timelines.
- Coordinate team activities related to audits, CAPA, and documentation control.
- Provide on-the-job training and performance feedback to QA team members.
- Ensure team compliance with QMS and regulatory standards.
- Support to the head of department QA in workload planning and resource allocation.
If you feel you are the perfect fit for the above position, please send us your details curriculum vitae along with a recently taken passport size photograph and the contact details of non-related referees within 7 days of the date of advertisement. Kindly state your expected salary & the position applied in the subject line and email your application to info@flexicare.lk
Manager – HR & Administration, Flexicare Lanka (Pvt) Ltd, No.382/X, Kumbuka Road, Raigama, Bandaragama. 038 2289992 / 038 2289977 / 038 2289947 / 038 2289982
www.flexicare.com