深圳招聘

Description:

The QA manager will manage quality systems, processes, and procedures to assure product safety and quality, as well as QMS and regulatory compliance by driving business alignment to our corp. Global QMS.

Key responsibilities include:

· Accountable for implementation of the our corp. Global Quality Management System at the site.

· Responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive Quality Management System implementation.

· Influencing site compliance to Quality policy and Quality Management System procedures.

· Ensuring training programs are current and employees are trained in accordance with latest regulatory requirements at a site or business.

· Provide leadership and coaching for the quality Control team.

· Ensure the timeliness testing of our products manufactured in our just-in-time process.

· Coach the quality Control team on the tools and practices required to drive day-to-day processes.

· Participate and lead qualification and validation of Quality Control equipment/ processes

· Initiate improvements in the quality of our processes.

· Participate in the plant-wide effort to reduce scrap and rework costs, and to identify root causes and solutions for quality defects.

· Ensure the meaningful and timely resolution of IR’s, CAPA’s, complaints and change controls.

Quality Specific Goals:

1. Aware of and comply with the corp. Quality Manual, Quality Management System (ISO13485:2003),Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

2. Complete all planned Quality & Compliance training within the defined deadlines

3. Identify and report any quality or compliance concerns and take immediate corrective action as required

4. Assure site and business is properly prepared for external and internal compliance inspections by the results of the inspections finding no systemic or warning letter findings.

5. 100% implementation of all quality system procedures, work instructions and requirements

6. Knowledge and understanding of document control, design transfer, verification, validation, acceptance activity, DMR, DHR and electronic signature requirements to ensure that product, equipment, tools, processes, software, training and documentation meet requirements.

Qualifications:

1. Bachelor’s Degree in Microbiology(or Science in Engineering or related field and 4 years of experience in leading a team

2. Minimum of 5 years experience working in a regulated medical device or pharmaceutical environment, quality control/assurance, or regulatory assurance

3. Knowledge in pharmaceutical regulations (GMP etc.)

4. Strong communication skills, verbal and written, also in English(or local language)

5. Working knowledge of Excel, Word, Power Point

Preferred Qualifications:

1. 10+ years Demonstrated experience in the medical device or pharmaceutical industry and knowledge of quality system regulations and policies

2. Experience with some or all of the following:

？ Design controls, design verification and validation activities

？ Production and process controls

？ CAPA, complaints and risk management

？ Understanding of product quality improvement using tools such as Six Sigma, DFR

？ Experience performing internal audits

3. Demonstrated ability to successfully comprehend & carry out/execute actions

4. Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging or frustrating circumstances

5. External Focus: Understanding customer needs, marketplace dynamics, industry trends, and the competitive landscape in the industry/function and considering the external impact of business activities and decisions on the external environment

6. Inclusiveness: Energizing others by building a connection with the team through personal involvement and trust and providing feedback and coaching to help develop others

7. Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly and concisely

8. 6-sigma DMAIC GB ,BB training

9. Experiences in Process Intensive manufacturing

深圳市卫特新康泰来医疗器械有限公司是美国伟亚安（Vyaire）在中国的全资子公司，位于环境幽静的龙岗区坪地教育北路高桥工业区飞莱特工业园，占地12000平方米。
主要产品为一次性麻醉面罩、一次性呼吸回路管及一次性鼻氧管等，主要销往美欧等地，其中麻醉面罩在全球同类产品市场中占领导地位。