SQA - (Senior) Engineer

About SHL Medical

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

To support risk-based approach audit events including audit preparation, audit awareness training and verify effectiveness of CAPA process. 

Main Responsibilities

• Responsible to follow all applicable SOPs and WIs at all the times.
• Responsible to follow the principle of GMP to the best of their ability at all times.
• General:
  a. Author procedures, work instructions or other documents.
  b. Provide training to other function members in QA systems.
  c. Interfaces with other functions' members, customers and/ or suppliers to resolve issues.
  d. Assist QA Manager by participating in Non-Conforming Product, complaint, CAPA investigation and improvement project.
  e. Drive corrective and preventive action (CAPA) activities
  f. Perform data analysis to drive continuous improvement project to meet department/ company goal and objectives.
  g. Carry out other duties as assigned.
• Audit:
  a. Responsible for internal audits program, ensure all QMS areas are adequately assess per procedure.
  b. Coordinate and organize 2nd and 3rd party accreditation audits.
  c. Participate in internal audits, and when require external audits.
  d. Training employees on GxP and quality standards and procedure to ensure audit readiness.
  e. Preparing and presenting quality audit report to senior management.
  f. Keep abreast of industry standards and regulations.
• Document Control:
  a. Maintain and management of the Document and Record control system.
  b. Review completeness of the Device History Records (DHR).
  c. Ensure Document Control activity is performed correctly.
  d. Work with Document Author, follow-up and carry forward the lifecycle of his/her documents and establish associations to the document.
  e. Execute the archiving and obsolescing of quality records.
  f. Control the distribution and return of QMS documents.
• Supplier Quality Audit and Management (SQA):
  a. Lead and draft Supplier Quality Agreement.
  b. Evaluate and audit supplier (routine and ad hoc).
  c. Review and approves supplier failure analysis relative to corrective action provided, and coordinate resolution of quality assurance related problems.
  d. Identify, investigate, analyze and correct problems in quality, production and control at a supplier location, and escalate to QA Manager if any major systemic/production failures observed.
  e. Drive supplier quality performance improvements.
• Cleanroom Testing and Control:
  a. Follow ISO 14644 and ISO 14698 to perform cleanroom environmental inspection.
  b. Manage microbiology lab in SHL Medical.
  c. Identify and classify microorganisms found in specimens collected from environment.
  d. Assist for cleanroom and working environment control, testing and monitoring.
  e. Responsible to lab maintenance and ensure GLP/GMP management.
  f. Evaluate cleaning effectiveness to determine robustness of disinfection.
  g. Investigate nonconforming inspection and support CAPA where applicable.
• Assign above job tasks by staffing qualification / personal ability / organization needs.
• Carry out other duties as assigned.

Minimum Qualifications

• Bachelor’s Degree in Engineering, manufacturing ,technical discipline, other related science is required.
• Minimum 3 years’ experience in Quality Assurance related function, Medical Device, Bio-Pharmaceutical or other regulated industry.
• Trained internal auditor in ISO 13485 / ISO 9001 or equivalent will be an added advantage.
• Experience in managing external quality audit will be an added advantage.
• Able to work well in a cross functional team and manage your own job load independently.
• Well-versed in English and Chinese, read, written and communicate.
• Attention to details, keen interest in compliance and continual improvement matters.

Preferred Qualifications

• Familiar with 21 CFR 820, ISO13485, cGMP is preferred.
• Knowledge of Quality Tools, auditing technique, problem solving skills is preferred.

We Offer

• Challenging assignments in a fast-growing and innovative industry.
• A multicultural team and modern working environment with state-of-the-art facilities and technologies.
• A place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth.
• Various opportunities for personal and professional development within a global organization.
• Flexible hours and hybrid working policy.