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Job Summary:
We are seeking a highly motivated and detail-oriented Manufacturing Quality Control Specialist to join our team. In this role, you will be responsible for designing, implementing, and monitoring quality control programs to ensure that products meet all specifications, quality standards, and regulatory requirements. You will play a crucial role in improving output quality, analyzing data and systems, and recommending changes to processes and standards. You will also collaborate with cross-functional teams to ensure that defects are reported and resolved in a timely manner.
Let's Talk About the Role:
Support the QC Team Leader in coordinating daily activities and prioritizing tasks to meet business objectives.
Assist in training, coaching, and mentoring the QC team to ensure consistent performance and development.
Ensure adherence to approved procedures, work instructions, and specifications during the production process.
Perform timely quality inspections using standard metrology equipment (e.g., digital calipers, Micro-Vu, Laser QC).
Manage non-conforming components, ensuring proper documentation, quarantine, and investigation before release.
Oversee the maintenance, filing, and archiving of inspection records to reduce backlog.
Release products efficiently while meeting business KPIs related to Quality, Delivery, and Cost.
Conduct document reviews and approvals to meet documentation KPIs.
Improve existing Quality Control processes for Goods Inwards, In-process, and Finished Goods inspections.
Ensure proper storage and maintenance of representative samples.
Comply with Health and Safety policies and participate in OH&S prevention activities.
Register new equipment and maintain records for equipment qualification, calibration, and maintenance.
Support general administrative duties related to equipment, calibration, and incoming/in-process inspections.
Participate in Material Review Board (MRB) meetings to resolve quality issues.
Ensure critical measurements are recorded in Lab Books, signed, and dated according to standards.
Maintain a clean, safe, and compliant workplace, following GMP and 6S standards.
Let's Talk About Skills and Challenges:
Teamwork: Collaborate effectively with team members, contribute to team goals, and share relevant information.
Leadership: Provide functional expertise to other departments with excellent communication skills.
Work Performance: Manage multiple priorities with strong organizational skills and attention to detail.
Compliance: Ensure compliance with FDA Quality System Regulations, GMP, and relevant ISO standards.
Let's Talk About Qualifications:
Required:
SPM with at least 6 years of industrial experience, or Diploma/Higher with at least 3 years of industrial experience.
Strong understanding of FDA Quality System Regulations, GMP, and ISO standards.
Experience in total quality management and best practices.
Proficient in Microsoft Office, Oracle, and other relevant software.
Preferred:
Experience in people management.
Experience in the Medical Device or Pharmaceutical industry.
Experience working in a manufacturing environment.
Join Us:
If you are passionate about quality control, have a keen eye for detail, and thrive in a fast-paced manufacturing environment, we encourage you to apply!
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Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!
