Quality Manager

2 weeks ago

Fremont, United States Evolve Manufacturing Full time

Company Overview:

Evolve is a leading contract manufacturer in the medical device industry, dedicated to producing innovative and high-quality medical devices. We are committed to exceeding customer expectations and maintaining the highest standards of quality and compliance. As we continue to expand, we are seeking a skilled and experienced Quality Manager to join our team and lead our quality assurance efforts.

Job Description:

As the Quality Manager at Evolve, you will be responsible for overseeing all aspects of our quality management system to ensure compliance with regulatory requirements and customer expectations. You will lead a team of quality professionals and collaborate with cross-functional teams to drive continuous improvement initiatives and maintain the highest levels of quality throughout our organization.

Key Responsibilities:

Manage and oversee the implementation and maintenance of the quality management system, ensuring compliance with ISO 9001, ISO 13485, and CFR 820. Lead Management Review meetings, reporting quality data results and providing insights to senior management to drive strategic decision-making. Host external audits, including customer audits and regulatory inspections, and ensure timely resolution of any findings or non-conformities. Provide leadership and direction to the Quality Engineering, Incoming Inspection, and Quality Control teams, ensuring effective management of resources and adherence to quality standards. Serve as the lead auditor for ISO 9001 and ISO 13485 certifications, conducting internal audits and leading audit teams to assess compliance and drive improvement. Liaise with customers to address quality-related inquiries, concerns, and requirements, ensuring a high level of customer satisfaction. Collaborate with cross-functional teams to identify and mitigate organizational risks related to manufacturing processes and product quality. Provide training and guidance to employees on quality management principles, regulatory requirements, and best practices. Stay informed about changes in regulatory requirements and industry standards, and proactively implement necessary changes to maintain compliance. Drive a culture of quality excellence and continuous improvement throughout the organization, leading by example and fostering a collaborative and supportive work environment.

Qualifications:

Bachelor's degree in Engineering, Quality Assurance, or related field; advanced degree preferred. Minimum of 10 years of experience in quality management roles within the medical device industry. Lead Auditor certification for ISO 9001 and ISO 13485 standards. Strong understanding of FDA regulations and experience with FDA audits; experience with the FDA program MDDAP preferred. Proven experience managing teams and leading quality assurance initiatives in a fast-paced manufacturing environment. Excellent communication and interpersonal skills, with the ability to effectively interact with customers, senior management, and cross-functional teams. Demonstrated ability to manage multiple priorities and drive results in a dynamic and evolving organization. Strong organizational skills and attention to detail, with the ability to effectively manage resources and ensure compliance with quality standards. Proactive and solutions-oriented mindset, with a commitment to continuous improvement and excellence. Ability to lead by example and complete work independently, without the support of a team.

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