Purpose

The purpose of Quality engineer is to establish a professional quality management system and to execute the quality control plan with a focus on helping and supporting the QC inspectors as they work to add value for BVI customers, as well as assist to processes verification and validation for global transfer projects until success launch. The Quality engineer shall assist Quality manager in creating a quality management system that will ensure all BVI-Changshu products pass the requirements of all laws and regulations, local and/or international, required for medical devices in all worldwide markets where BVI competes.

Key Responsibilities

• Be responsible for the preparation, review, and training of quality management system.
• Be responsible for the preparation, review, and maintenance of quality related SOPs.
• Annual internal and external audit of quality management system: organize the internal audit, coordinate, and complete the external audit, and track the rectification measures of non-conformities.
• Be responsible for the all processes verification and validation, to assist the global transfer projects launch.
• Lead in handling customer complaints, organize the team to analyze the complaints, formulate corrective and preventive measures, and complete the verification.
• Supervision and management of document control, distribution and archiving.
• Be responsible for training QC team on corresponding quality tools, methods, and abilities to improve the inspection consistency.
• Investigate and analyze abnormal in production and find solutions (involving process, control methods, tools and equipment, raw materials, etc.);
• Assist in supplier quality management, be responsible for formulating containment measures and cause analysis of defective materials and supervise supplier continuous improvement.
• Assist in daily management of QC team to ensure all key process control points are inspected as required.
  
  

Qualification

• College degree or above.
• At least 5 years working experience in quality management.
• Familiar with ISO13485 and ISO9001.
• Be familiar with and master the medical quality certification system and certification process,and the validation process, such as CE, EU, MDR, etc.
• Data statistics and analysis ability, and be familiar with SPC, MSA, GR & R and other quality management methods.
• Good thinking and logic skills, interpersonal and communication skills.
• Familiar with office software;
• Have experience in team management.
• Have leadership ability and the ability to analyze, judge and deal with problems.
• Good communication skills, dealing with cross departmental issues.
  
  

Company

BVI® is refocusing the future of vision.

As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.

We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.

Learn more at www.bvimedical.com