Manufacturing Manager Job at Schivo in Plainview

Overview Job Title: Manufacturing Manager Department: Operations Location: Schivo, Plainview, NY Reports To: Site Director Job Type: Full-Time Industry: Medical Device Contract Manufacturing Job Summary The Manufacturing Manager is responsible for the management and oversight of Production Operations for our Plainview facility. This role ensures that all Manufacturing activities meet customer requirements, quality standards, and regulatory requirements (e.g., FDA, ISO 13485). The ideal candidate will have strong leadership skills, deep knowledge of manufacturing processes, and a commitment to continuous improvement in a fast-paced, regulated environment. Key Responsibilities Lead all Manufacturing operations to meet and exceed KPIs in productivity, quality, cost, safety, and customer service Build and maintain an effective operations management system grounded in Lean and Growth principles In conjunction with site leadership, deliver on the site\'s Annual Operating Plan, aligning with broader business goals Ensure adherence to FDA regulations, ISO 13485 standards, and Good Manufacturing Practices (GMP) Work closely with Quality Assurance and Regulatory teams to support audits, validations, and documentation Ensure Manufacturing operations are fully compliant with safety, environmental, and quality standards (HS&E, QMS) Drive manufacturing team level engagement, resolve people issues proactively, and promote a positive, accountable team culture Manage and develop a high-performing team, ensuring the right skills, behaviours, and mindset are in place Lead, coach, and develop a team of supervisors, technicians, and operators Foster a culture of accountability, teamwork, and continuous improvement Champion a culture of continuous improvement using Lean tools and methodologies and cross-functional collaboration with Operational Excellence, Quality, Automation and Engineering teams Implement Lean Manufacturing and Six Sigma tools to drive operational excellence In conjunction with engineering and quality, lead the introduction of new products, processes, and technologies into manufacturing Qualifications Bachelors degree in Engineering, Manufacturing, Life Sciences, or a related field 5+ years of experience in a medical device or regulated manufacturing environment, with at least 2 years in a leadership role Skilled in developing cross-functional teams and building organizational capability Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and GMP requirements Familiarity with Lean manufacturing principles; hands-on Lean experience highly desirable Proven ability to manage teams and meet Manufacturing targets in a highly regulated industry Proficient in SAP ERP, Microsoft systems and comfortable operating in a data-driven, KPI-focused culture Preferred Skills Lean/Six Sigma certification (Green Belt or higher) Strong problem-solving, communication, and interpersonal skills Work Environment Primarily manufacturing floor with some office work. Use of personal protective equipment (PPE) and adherence to cleanroom protocols as required. May require occasional shift work or extended hours based on Manufacturing needs. Salary: up to $120,000 per year #J-18808-Ljbffr