Quality assurance expert
the successful candidate will be responsible for providing leadership, expertise, direction, and guidance to our organization and quality culture. As a quality manager, you will plan, develop, execute, control, and monitor 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.
this role requires a high level of validation knowledge, experience with statistics and problem-solving tools, and advanced quality planning skills. You will also provide support and communicate 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.
the ideal candidate should have more than 10 years of experience in a medical device manufacturing environment and managing a quality engineering group as a quality manager. They should also have knowledge of quality systems that comply with international standards, preferably 13485:2016, mdsap, eumdr, and fda. Additional requirements include excellent written and verbal communication skills, teamwork/team building skills, influencing and negotiating skills, and a high level of gmp and fda regulatory knowledge.
we are looking for someone with a degree in engineering or administration, master's degree, project management skills, or other related certifications. Bilingual spanish- english is highly preferred.
key responsibilities:
- plan, develop, execute, control, and monitor the quality management system
- provide leadership, expertise, direction, and guidance to our organization and quality culture
- ensure that all quality and organizational objectives and goals are met, as well as improvements in quality, operations, processes, systems, and product development
- provide support and communicate with various organizational groups to resolve design and other issues related to process, product, or system matters