NJ Employer Operations Manager - Medical Device, Process Engineer, manufacturing (772226) in Warren, New Jersey

DescriptionSummary: Responsible to achieve device manufacturing and engineering (M&E) operational objectives in support of clinical trial execution, product launch, quality, customer satisfaction, cost and safety.DescriptionAccountable for the achievement of goals for device M&E operational performance, quality and customer satisfaction in a team environment.Defines and modifies device M&E project scope and timelines using project management techniques and tools.Manages operational risks and executes projects to meet business goals. Communicates project management plan and status to key stakeholders.Contributes to, and coordinates project deliverables with concomitant projects.Provide process design leadership to commercialize the Delivery System.Develops process specifications, implementation and validation.Facilitates key product and process decision makingIdentify, develop and accomplish key initiatives supporting the business objectives and Device Engineering and Manufacturing goals for project management, management reporting and resource managementKeeps SOPs and processes current as improved business practices are implemented; stays current of internal SOPs and regulatory guidelinesRequirementsBachelors degree in engineering discipline required, Masters degree preferred.PMP certification highly desired2-4 years in medical device or related industry a must5+ years manufacturing operations, supply chain and project management experience.Demonstrated strong leadership, communication, influencing and collaboration.Interpersonal, influencing, negotiation and team management skills; advanced project management and project coordinationAbility to solve complex problemsIn depth understanding of cGMP requirements (FDA 21 CFR Part 820), ISO 13485 and other regulatory requirements.Proficiency in using project management and standard office software.**For immediate consideration, please email your updated resume to cbeltran@apexlifesciences.com with "Operations Manager - Medical Devices" in the subject line.EEO EmployerApex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.VEVRAA Federal ContractorWe request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here. https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf