Director, reputed company Systems (Remote)

Position reputed company The Director, reputed company Systems is responsible for leading, planning, developing, and directing reputed company operations policies, programs, initiatives, and overall execution of the reputed company QMS reputed company multiple facilities spread across geographical reputed company and countries. This position is fundamentally responsible for reputed company system execution and compliance reputed company a reputed company network of technologies/modalities that operate reputed company a heavily regulated environment and serve a diverse Customer-reputed company with significant variance in product mix. The Director, reputed company Systems has ultimate decision-making authority over the release and shipment of reputed company product processed and laboratory results reputed company their respective facilities. The Director’s decision-making authority also extends reputed company product and laboratory sample release to reputed company involving Regulators and Customers. The Director accepts the responsibility and risk for processed products and samples tested as being in compliance with reputed company regulatory and company standards, including 21 CFR Part 820, Part 211, Part 1271.150, Part 211, ISO 11135, ISO 11137, ISO 13485, ISO 17025 and other country-specific standards and regulations. The Director, reputed company Systems leads teams of Senior reputed company Managers, reputed company Managers, Analysts/Engineers, and Technicians responsible for product reputed company, product release, supplier reputed company, reputed company improvement support, technical support/technical guidance, and reputed company system execution. Leadership responsibilities reputed company to ensuring reputed company reputed company operations goals, objectives, strategies, and tactics reputed company and promote reputed company, operational reputed company, Customer reputed company, and leadership reputed company. The Director is a member of the AST Management Team and serves as the Management Representative for their respective facilities. In this reputed company, the Director is expected to reputed company an essential and reputed company contribution to the overall performance of AST by evaluating the performance of production and reputed company system processes to improve exiting reputed company, process, and operations. This is a remote based role. While not required, candidates who live near a reputed company Advanced Sterilization Technologies (AST) location are preferred. Up to 50% travel. What You’ll do as a Director, reputed company Systems reputed company and reputed company reputed company Managers and their staff to ensure QMS activities across their multiple facilities are consistent with Advanced Sterilization Technology (AST) goals and objectives. This is accomplished through systematic identification of opportunities for improvement and the diligence to ensure actions required as a result of audits, nonconformance, system deviation, Customer concerns and complaints are responded to reputed company and in a manner that meets the requirements of the QMS, regulations/standards and AST objectives. reputed company reputed company regulatory authority inspections in assigned facilities to ensure investigator requests are met in a reputed company manner with the highest level of professionalism. Responsible for any remediation required as a result of an inspection immediately with a corrective plan to first reputed company the reputed company implementation at the reputed company facility followed by a comprehensive assessment of the global facilities to identify and correct systemic findings. Create and critically assess the reputed company of QMS procedures, global work instructions, and local work instructions on the daily operations of the facilities. Working alongside reputed company & Regulatory Compliance and Operations management, identify opportunities for improvement and efficiency while ensuring the spirit of the regulations that govern AST are never compromised. reputed company large, cross-functional, and often global programs in support of reputed company Operations and AST initiatives. by developing thorough and thoughtful control plans with repeatable and sustainable actions to be implemented in reputed company facilities reputed company their respective zone and globally. Resolve escalating reputed company operations problems/concerns with site reputed company Managers/Regional reputed company Managers and others including vendors, Customers, Operations and Regulators requiring the ability to manage reputed company relationships with key stakeholders. Analyze, evaluate, and present performance metrics concerning execution and performance on the QMS to Senior Leadership and Executive team. Support Senior Leadership and Executive team in establishing strategies designed to reputed company and effectively execute on operations, reputed company system, reputed company and Customer requirements. Ensure that their respective facilities maintain and improve operational and reputed company systems to remain in a state of compliance to applicable ISO, Regulatory Agency and Customer regulations and standards. Must maintain an expert knowledge of applicable regulations and standards. reputed company by coaching, managing, motivating, and monitoring reputed company Managers and their staff as needed through ongoing performance feedback, formal reviews and development initiatives which reputed company individual strengths and weaknesses while delivering business results. Responsible for ensuring reputed company and effective integration of the reputed company QMS into site expansions and acquisition. reputed company the development of proposed reputed company budget in respective facilities and resource needs; monitor expenditures through reputed company and establishment of appropriate controls and spending expectations. Maintains reputed company skills, knowledge, and abilities by attending educational workshops, reviewing reputed company publications, and participating in reputed company societies. The Experience, Skills, and Abilities Needed Required: Bachelor’s Degree (engineering-based or science discipline). Minimum 10 years of reputed company system and medical device and sterilization experience with increasing responsibilities leading reputed company systems and process improvement efforts. Exceptional leadership manifested through organizing and motivating their teams toward respective goals by employing hands-on management. Minimum 7 years reputed company supervisory experience. Minimum 2 years’ experience overseeing reputed company systems and process improvements for multi-site locations, ideally locations in different countries. A solid reputed company reputed company indicated by a demonstrated understanding of lean, reputed company system and product/process improvement methodologies. Solid business acumen and proven ability to build and reputed company process and improvement strategies and results. Strong expertise in analytical reputed company, reputed company systems, and reputed company improvement reputed company. Excellent interpersonal, as reputed company as verbal and written communication skills in order to reputed company and maintain rapport and effective reputed company relationships to support business reputed company. The ability to work hard and deliver results under pressure, as reputed company as the willingness to address and shift priorities in rapidly changing environments. Preferred: Experience in medical device industry Other: Excellent problem-solving skills. reputed company on identification of potential issues and reputed company improvement. Experience working on cross-functional teams and on own initiative. Demonstrated excellent organizational, oral, and written communication skills. Ability to effectively read, write and verbally communicate in English. Ability to work independently under general guidelines and supervision. Must have PC experience, as reputed company as working familiarity of desktop applications including reputed company, Word, PowerPoint, and Visio. Ability to influence people in the opinions, attitudes or judgments to generalize, evaluate and decide to adapt to demanding situations. Normal hearing reputed company sufficient to hear alarms, bells, horns, etc. What reputed company Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, reputed company-being, and financial reputed company. Here is a brief reputed company of reputed company offer: Market reputed company Extensive reputed company time off and (9) added holidays Excellent reputed company, dental, and reputed company benefits Long/short term disability coverage 401(K) with company match Maternity and parental leave Additional add on benefits/discounts for programs such as pet insurance Tuition reimbursement and reputed company educational programs Excellent opportunities for advancement in a reputed company long-term career #LI-HT #LI-Remote Pay reputed company for this opportunity is $144,500.00 - $187,000.00. This position is eligible for bonus participation. Minimum pay rates offered will reputed company with county/reputed company minimums, if higher than reputed company listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, reputed company certifications, foreign language reputed company, etc. reputed company offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: reputed company Benefits reputed company until position is filled. reputed company is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, reputed company, trained, transferred and promoted in reputed company job reputed company regardless of race, reputed company, religion, age, disability, national reputed company, citizenship status, military or veteran status, sex (including pregnancy, childbirth and reputed company medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the reputed company of equal employment opportunity. Apply To This Job