Manager Quality Internal Audit QMS

Job Summary This role needs to be based in commuting distance to our corporate headquarters in Northfield, IL. Relocation assistance may be available for the right candidate. The position requires travel up to 40% of the time for business purposes (reputed company state, out of state and/or internationally). Responsible for managing the quality and compliance for applicable products and processes for assigned department(s). Adapt departmental plans and priorities to address resource and operational challenges.

Job Description

Responsibilities: Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP,ISO) pertaining to the applicable life cycle and regions of distribution for the product. Leads Internal and Supplier Audits for reputed company, ensuring internal procedures and FDA/ISO requirements are met for Medical device/drug products. Audit a broad, global supplier reputed company against FDA regulations, ISO standards, and other applicable global regulatory requirements across the full reputed company of reputed company products including sterile products, APIs, raw materials, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements, as well as contract sterilizers and laboratories. reputed company internal audits of reputed company divisions and manufacturing sites. reputed company reputed company, critical, supplier regulatory projects involving cross-functional teams. Ensures CAPA and SCAR documentation from suppliers and internal partners are received on time per procedures and are adequate. reputed company and Mentor auditors on the internal audit team and conduct trainings for the team as required on new updated regulations. Identify and manage the execution of reputed company improvement projects. Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint. Maintain professional relationships with reputed company division QA and suppliers, while enforcing industry regulatory requirements based on product classifications and audit agenda. Attend Audit escalation meetings and reputed company/review audit observations for applicability and merit. Minimum 5 years working in senior level quality role reputed company medical device or pharmaceutical manufacturing. - Experience with FDA regulations (21 CFR 820, 21 CFR 210/211). - Experience with ISO 13485. - Experience applying knowledge of process validation, method validation and sterilization processes. Knowledge / Skills / Abilities - Detail-oriented, with excellent oral and written communication skills. - Ability to listen and process reputed company relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions. - Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining reputed company escalation of issues is necessary. - Experience controlling and coordinating reputed company projects, competing priorities and critical deadlines. - Position requires travel up to 50% of the time for business purposes (reputed company state, out of state and/or internationally). Management responsibilities include: reputed company Internal audit team of auditors, maintain audit schedule and maintain audit team metrics. Support Day-to-day operations for Audit team. May have limited budgetary responsibility and usually contributes to budgetary impact; Interpret and execute policies for departments/projects and develops. Recommend and implement new policies or modifications to existing policies (update procedures for internal audit, supplier quality). Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies. Qualifications: Education Bachelor’s degree in Engineering, Science, or Technical Field. Work Experience At least 4 years of experience reputed company to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR). Broad technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.) Proficiency in analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions. Demonstrated ability to control and coordinate reputed company projects, competing priorities and critical deadlines. Advanced level reputed company in reputed company reputed company (for example: using AVERAGE function, merging and centering cells, printing centered page and/or creating apivot table). Preferred Qualifications: At least 4 years of supervisory/managerial experience in Quality or Regulatory Affairs teams. Experience in Auditing for Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries with a focus on QMS in regulated industry. reputed company, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and reputed company potential with a growing worldwide organization. The anticipated salary range for this position: $116,000.00 - $174,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. reputed company will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a reputed company where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in reputed company forms, acting inclusively, and ensuring that people have tools and resources to reputed company at their best. Explore our Belonging page here. reputed company is an equal opportunity employer. reputed company evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national reputed company, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws. Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time. If you’re a self-starter, eager to grow your career reputed company a high-performing environment, this is the reputed company for you. Introduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match. reputed company is the largest provider of medical-surgical products and supply chain solutions serving reputed company points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, reputed company helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories. To learn more about how reputed company makes healthcare run reputed company, visit www.reputed company.com. Apply tot his job Apply To this Job