Regulatory Compliance Manager

About Us:How many companies can say they have been in business for over 178 years?!Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the ever-changing environments in a fast-paced world, meeting it with cutting edge technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!What’s the role?The Quality Engineer serves as a key quality assurance resource, providing hands-on support to ensure ongoing product manufacturing aligns with established quality and regulatory standards. This position works very closely with the Manufacturing Engineering team, is directly involved in day-to-day production processes, and can act as a backup for all quality-related responsibilities.Sound Interesting?Here’s what you’ll do:Identify and assist with process validation activities.Support projects related to manufacturing plant layout/process to ensure efficient and timely completion.Manage multiple projects in various stages of production, including, process improvements, quality inspections, and quarantine and inventory control.Lead risk management activities such as verification of risk mitigation implementation in products and processes (PFMEA).Assist with design transfer to manufacturing, including quality control activities from production processes to shipment of the final product.Inspect product including labeling and documentation for release of finished goods.Assist with Operations and Engineering to ensure that all production employees are familiar with, trained on, and follow all manufacturing procedures related to their jobsEnsure that changes to procedures are reviewed, approved and validated prior to implementation.Oversee creation and review of documentation for nonconforming products.Provide quality engineering support and expertise in the investigation of nonconformances and CAPAs.Works with Engineering department ensuring that engineering change orders affecting production related changes are reviewedKeep management informed of significant issues identified during production-related quality activities as well as actions being taken to improve and correct the situation.Assist with revisions and updates to quality procedures, standardized work instructionsParticipate in supplier management activities. Identify supplier quality issues and report to management in timely manner.Participate in 3rd party audit and inspection activities (ISO, Notified Body, FDA etc.).Other duties as assigned.Do you qualify?Solid understanding of quality system requirements set by the major regulatory frameworks for medical devices and combination products.Relevant experience in managing and overseeing quality aspects in distribution, preferably in disposable devices as well as pharmaceutical products.Ability to effectively translate quality requirements into practical directions for the organization.Experience in management of FDA and/or Notified Body inspectionsHigh level of integrity and ethical standards.Ability to multi-task and methodically manage projects based on business priorities and resource availability.Ability to self-motivate and work independently in a geographically separated multi-national and multi-functional team environment.Collaborates effectively across a diverse network.Open-minded for improvement opportunities and change towards striving for best-in-class compliance performance.Ability to think creatively, proactively identifying alternative solutions to problems.Experience in people management.Effective communication/interpersonal skills.Fluent in English (written and spoken)The role requires up to 25% travel to New Britain, PA, with the remaining time divided between the Exeter & Seabrook, NH locationsAdvanced level in Microsoft Office suite applications.Minimum Bachelor degree in a relevant field of engineering.Qualification in Quality Assurance (e.g. six-sigma, lean, ASQ).Minimum 5 years in a senior role in Quality Assurance in medical device or pharma industryWe have amazing benefits to support you as an employee at Dutch Ophthalmic!Medical – 90% employer paidDental – 100% employer paidLife Insurance, AD&D, STD & LTD Insurance – 100% employer paidVision401k MatchingPaid Leave: Sick, Vacation and HolidaysThe list goes on!The above is intended to describe the general content of and requirements for this job. It is not to be construed as an exhaustive statement of requirements, duties, or responsibilities. The Company reserves the right to interpret, amend, or otherwise modify, in whole or in part, any job description at any time, at its sole discretion.Your ZEISS Recruiting Team:Jo Anne MittelmanZeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends). #J-18808-Ljbffr