🌐Boston Scientific Medical Device (Malaysia) Sdn. Bhd.
Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We are a leading innovator of medical solutions that improve the health of patients around the world. Our products and technologies are used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular, urological, women's health, and chronic pain conditions.
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen. We continue to innovate in these areas and are extending our innovations into new geographies and high-growth adjacency markets.
- Primary Commitment to patient safety and product Quality
- Understands and comply with all the regulations governing the quality systems.
- Delivery of key Quality and Performance Objectives. Maintenance of laboratory scorecards and trackers.
- Ensure compliance with mandatory training requirements and ensure that your training records are up to date and compliant to cGMP.
- Your responsibilities may include test method development and validation, raw material, in process, finished product and Stability testing.
- Complete documentation associated with testing/ method development & Validation/ equipment qualification in a timely manner.
- Ensure all analytical testing is carried out as defined in the Quality System.
- Perform equipment calibration and qualification as required.
- Review of all laboratory Quality Systems to ensure compliance to cGMP.
- Participate in Regulatory, Internal (Auditor/Auditee) and Vendor audit programs as required.
- Provide training (induction/ on the job/ procedures and updates), technical guidance / trouble shooting to laboratory staff including review of associated training records.
- Review and approval of Laboratory results and documentation, as required the trending and charting of data.
- Perform and assist with additional duties as may be directed by the QC supervisor.
- Proficient in the use various software application utilized in the laboratory. As required the development configuration and validation of software in accordance with Boston Scientific and Industry standards.
- Create, review and approve change requests as required. Where required approve CR’s as laboratory trainer.
- Creation of purchase requisitions for laboratory equipment and consumables.
- Management of laboratory spend and approval of vendor invoices.
- Management of laboratory inventory and supplies and ordering of same.
- Manage laboratory training process and maintenance to training status.
- Provide analytical support to process validations.
- Participate on LBP/VIP and Continuous project teams as required.
- Candidate must possess at least a Bachelor's Degree in Chemistry, Engineering (Chemical), BioTechnology, Engineering (Bioengineering/Biomedical) or equivalent.
- Required skill(s): Strong chemical analytical skills. Laboratory controls skills for testing and releasing of chemicals. Problem-solving and continuous improvement skills. Good inter-personal and stakeholder management skills.
- Required language(s): English
- At least 5 year(s) of working experience in the related field is required for this position.
Location: Penang, Malaysia
Benefits: Dental, Education support, Miscellaneous allowance, Medical, Sports (e.g. Gym), Parking, Vision, Regular hours, Mondays - Fridays, Business (e.g. Shirts)
Boston Scientific Medical Device (Malaysia) Sdn. Bhd.
PMT 741, Persiaran Cassia Selatan 1,
Taman Perindustrian Batu Kawan
14110 Bandar Cassia
Pulau Pinang, Malaysia