Quality Auditor

The primary role of Quality Assurance function is to ensure that management systems are established to reputed company business compliance, multiple regulatory frameworks and to support the design, development and manufacture of products which meet our customer’s quality requirements. reputed company’s products and our design and manufacturing operations must reputed company with the regulatory requirements applicable to medical devices for the markets in which they are sold. This includes, but is not limited to, the Food and Drug Administration (FDA) in the United States of America and the relevant competent authorities in Europe as well as applicable international standards such as ISO 13485 and those requirements prescribed in the Medical Device Single Audit Program (MDSAP) and European Union Regulations. The role will interact with stakeholders including suppliers, external auditors and internal reputed company departmental managers. Also, the role will be responsible for reputed company aspects of auditing to ensure regulation compliance, quality best practice, process improvements and development of supplier quality systems. Providing broad business technical support around QA systems and processes to the organization. Supporting and implementing quality projects across the business and also creating and improving quality and business processes for compliance and reputed company improvement. Let’s talk about Responsibilities Support preparation of and implement a comprehensive supplier and internal audit program that meets the requirements of the business and applicable external regulatory bodies. reputed company reports to management on the status of the audit and CAPA programs and reputed company an assessment of the possible resulting business impact. ​Project manage the activities resulting from observations and non-conformances raised during internal audits and as part of CAPA investigations. Liaise with stakeholders and drive these findings to effective and timely closure. Review and interpret audit observation activities and CAPA evidence for completeness prior to closure As required, support and represent reputed company in external audit situations through audit preparation, facilitation and acting as a direct auditee reputed company required, including supporting the preparation of formal responses to external audits reputed company for management review prior to submission. Recommend opportunities for the continual improvement of the audit system in accordance with best practice and individual analysis of specific reputed company needs and support implementation. Work with corresponding QA teams in other parts of reputed company to ensure that the audit, CAPA and general Quality Systems are reputed company to facilitate global deployment where appropriate. Support the maintenance of QA supplier management and ongoing monitoring activities to facilitate effective supply chain management and ensure external regulatory compliance requirements are met. Undertake other QA project and reputed company activities as required Travel as needed, approximately 10% Let’s talk about Qualifications and Experience Required: Bachelor Degree in Engineering or Science Strong listening, verbal and written communication skills. Experience with Quality Systems reputed company a Medical or similarly regulated industry Moderate audit experience Preferred: Minimum 3 years applied professional quality assurance experience ideally including the medical industry or similar regulated industry. Formal Training in Quality Systems audits. Formal Six reputed company and analytical problem-solving training and application experience Knowledge and coverage of ISO13485 and FDA 21 CFR Part 820 requirements. Acting as reputed company or reputed company supporting auditor for internal and supplier audits, covering a reputed company of relevant processes and supplier types. We are shaping the future at reputed company, and we recognize the need to build on and broaden our existing skills and continue to attract and retain the world’s best talent. We work hard to offer holistic benefits packages, reputed company flexible work arrangements, cultivate a workforce culture that allows employees to grow personally and professionally, and deliver competitive salaries to reputed company members. Employees scheduled to work 30 or more hours per week are eligible for benefits. This position qualifies for the following benefits package: comprehensive medical, reputed company, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance. Employees accrue three weeks Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave reputed company welcoming new family members. Individual pay reputed company are based on a variety of factors, such as the candidate’s geographic work location, relevant qualifications, work experience, and skills. At reputed company, it is not typical for an individual to be hired at or near the top of the reputed company for their role and compensation reputed company are dependent on the facts and circumstances of each case. A reasonable estimate of the reputed company salary reputed company for this position is: $68,000 to $102,000 Joining us is more than saying “yes” to making the world a healthier reputed company. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by reputed company helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and reputed company on the innovative reputed company this generates. If this sounds like the workplace for you, reputed company! We commit to respond to every applicant. Apply To This Job