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bvi is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, bvi partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors. Our trusted brands include beaver (knives and blades), visitec (cannulas), malosa (se instruments), vitreq (vitreoretinal surgical products) and physiol (premium intraocular lenses).
qa manager
the juarez mexico quality manager provides leadership, expertise, direction, and guidance to bvi's organization and quality culture. Qa manager plans, develops, executes, controls, and monitors the quality management system to ensure that all quality and organizational objectives and goals are met, as well as improvements in quality, operations, processes, systems, and product development. He or she will also ensure that the transfer and acquisition of processes and projects are implemented efficiently and effectively. He or she will be responsible for providing support and communicating with various organizational groups, such as quality, operations, sales, marketing, customer service, supply chain, regulatory departments, medical affairs, design development, procurement, and supplier management, as well as customers, to resolve design and other issues related to process, product, or system matters.
knowledge and experience:
* more than 10 years of experience in a medical device manufacturing environment and managing a quality engineering group as a quality manager.
* knowledge of quality systems that comply with international standards, preferably 13485:2016, mdsap, eumdr, and fda and other regulations.
* previous experience in people management and problem-solving, advanced quality planning, and medical device product validation.
additional requirements:
• knowledge of the significant change process.
• excellent written and verbal communication skills.
• influencing and negotiating skills.
• high level of validation knowledge.
• experience with statistics and problem-solving tools.
• advanced quality planning, product validation, qsr, and iso 13485 and 9001, mdd, mdcas, jpal, mdsap, and eumdr.
• high level of gmp and fda regulatory knowledge.
• excellent project management skills.
• high attention to detail, speed, solutions, and customer service.
• highly standardized, well-organized, and meticulous work.
• excellent planning and organizational skills.
• highly proficient in number management with good verbal reasoning skills
• customer-focused and customer-oriented
• demonstrable coaching and leadership skills. Knowledge of applicable production processes, prior experience with product transfer/start-ups, and a proven track record of working in a fast-paced manufacturing environment managing multiple projects is highly preferred.
level of education:
* degree in engineering or administration. Master's degree, project management skills, or other related certifications.
seniority level
* seniority level
mid-senior level
employment type
* employment type
full-time
job function
* job function
engineering and quality assurance
* industries
medical equipment manufacturing
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