Quality Regulatory Medical Devices jobs

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Advancing possibilities for a brighter tomorrow

Boston Scientific is seeking a highly motivated Lab Technician S1 on a defined-term basis to join our team.

Purpose:

To perform routine Analytical testing as assigned and to accurately document test results.

They are responsible for ensuring that all testing is carried out in line with all quality system and regulatory requirements.

Responsibilities

Key Responsibilities:

• Demonstrate a primary commitment to patient safety and product quality.
• Understand and comply with all the regulations governing the quality systems (including ISO 17025 for accredited laboratory).
• Delivery of key Quality and Performance Objectives.
• Conduct testing according to written procedures, Raw material, in-process and finished product testing in the Analytical laboratory.
• Collect, compile and analyse data and prepare laboratory reports.
• Ensures all notebooks/logbooks/Worksheets/ELN files are completed and reviewed in a timely manner.
• Records all information and raw data only on designated forms or logbooks and/or via appropriate systems.
• Assist manufacturing/operations/quality in solving quality-related problems.
• Ensures NCE’s, laboratory investigations and out of specification results are documented and reported to Laboratory Management.
• Ensure equipment, standards and other materials are approved/released prior to use.
• Performs cleaning, preventative maintenance, verification of instruments and equipment where required.
• Ensure all training is completed as per Laboratory Training Program.
• Support Internal/External Audits.
• Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.
• To build quality into all aspects of work by maintaining compliance to all quality requirements, including Good Manufacturing Practice, Good Laboratory Practice and Good Documentation Practice (GMP, GLP and GDP).
• Perform and assist with additional duties as may be directed by the Supervisor.
• Identify and implement opportunities for improvement.

Requirements:

• NQF Level 6 or above in STEM Discipline.
• Required experience and Product Knowledge in Analytical Lab.
• Minimum 1year experience in a Laboratory or Quality environment, preferably in a medical device background.

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.