**Why Patients Need You.** The primary responsibility of the position is to act as the Rocky Mount site subject matter expert of regulations specific to medical devices and combination products. This position is responsible for ensuring activities such as change control, design transfer, and CAPA are completed in a manner that is compliant with regulations and procedures. This person will also be the liaison between the plant and the Design Center for all projects and changes related to Medical Device and combination products. **How You Will Achieve It.** + Work as a liaison between the Design Center and Rocky Mount for all Medical Device and Combination Product projects as well as life cycle management of existing products. + Ensure the appropriate application of design control for change control management and Design Transfer. + Ensure the appropriate application of Medical Device risk management principles for Risk File review and pFMEAs activities at the site. + Support Medical Device/Combination Product investigations by applying applicable FDA CAPA requirements. + SME during internal and external inspection related to Medical Device Quality Systems. + Work with all functional areas to understand processes and potential impact to Medical Device/Combination Products when changes are implemented. + Educate all functional areas on the requirements associated with Medical Device and Combination Products. **Qualifications** **Must-Have.** + Applicant must have a Bachelor's degree with at least 4 years of experience; OR a Master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an Associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of **relevant** experience + Pharma or Device experience + Experience in FDA Quality System (21CFR 820 Regulations) and ISO 13485 + Experience in Medical Device Risk Management Activities including ISO 14971 **Nice-to-Have.** + 5 years of experience in Medical Device related fields + ASQ CQE certification + Advanced statistical training + Experience facilitating and coordinating compliant Device CAPA site governance processes. + Experience at a medical device manufacturer in a design quality role. **Physical/Mental Requirements.** The position may require lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform complex data analysis. The incumbent may be required to stand up for periods of up to 4 hours, use a computer for up to 8 hours and walk up and down stairs. **Non-Standard Work Schedule, Travel, or Environment Requirements.** The position may require some extended workdays and weekend work to ensure the review and approval of quality investigations in accordance with pre-established performance metrics and/or agreed upon schedules. The position is required to adhere to all safety policies and procedures along with cGMP, regulatory requirements, internal Standard Operating Procedures (SOPs) and Pfizer policies and standards. Travel for this position is minimal to none. Relocation support available. 1st shift role. Work Location Assignment: On Premise The annual base salary for this position ranges from $102 900,00 to $171 500,00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15,0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. **Sunshine Act** Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. **EEO & Employment Eligibility** Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Quality Assurance and Control