Sr. QO Specialist, Medical Device

Why Patients Need You Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team.
We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission.
Patients need colleagues like you who take pride in their work and always look to improve outcomes.
You will help to ensure that patients and physicians have the medicines they need, when they need them.
What You Will Achieve This role is responsible for execution of Kalamazoo site Quality Systems for Medical Device/Combination Products having responsibility for the support of those products, globally.
The role interfaces heavily with colleagues in QO, Continuous Improvement, Manufacturing, Procurement, Engineering, and site leadership.
This role also supports inspection readiness and compliance with all applicable medical device and combination product regulations within the scope of the manufacturing site’s activities.
How You Will Achieve It Work with, support, and help coordinate colleagues across the entire Kalamazoo site, other Pfizer sites, above-site Pfizer colleagues, Pfizer customers, Pfizer suppliers and External Inspectors.
Participate in the site and network-wide teams to provide alignment and support on key items such as Trend Review Board (TRB), The CAPA Program/CAPA Review Board (CRB), and Device Quality Management Review Team (DQMRT).
Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
Demonstrate good planning, organizing, time management and team participation skills.
Clearly communicate progress and issues to peers.
Lead and train colleagues on one or more of the following site programs: Medical Device CAPA Coordinator.
Medical Device Combination Product (MDCP) Support.
Including MDCP CAPA QTS/eQMS module administrator.
Trend Review Board (TRB): Create TRB presentations for monthly meetings and publish agenda for each meeting Maintain TRB topic schedule and schedule meetings Notify presenters of responsibilities for actions and follow-up on action items Gather data for quality metrics and evaluate for meeting/exceeding thresholds and possible escalations to MDCP CAPA Leads TRB meetings Present TRB summary at CRB and DQMRT meetings Generate, Receive Approval and Distribute Meeting Minutes MDCP CAPA Review Board (CRB): Create CAPA Review Board presentations for bi-weekly meetings and publish agenda for each meeting Maintain CRB topic schedule and schedule meetings Notify presenters of responsibilities for actions and follow-up on action items Gather data for nonconforming incidents and evaluate for possible escalations to potential MDCP CAPA Gather data for MDCP CAPA metrics and present at DQMRT Coordinate as needed with MDCP CAPA Manager Generate, Receive Approval and Distribute Meeting Minutes Device Quality Management Review Team (DQMRT): Create and maintain the site quality plan / quality metrics Create DQMRT presentations for quarterly meetings and publish agenda for each meeting Maintain DQMRT topic schedule and schedule meetings Notify presenters of responsibilities for actions and follow-up on action items Generate, Receive Approval, and Distribute Meeting Minutes Provides support for MDCP Internal & External Audits and regulatory inspections and participates in internal GMP audits.
Authors, reviews and / or approves GMP related SOPs and documents.
Monitors ongoing industry quality and regulatory compliance matters applicable to device/combination products and ensures required updates are implemented in a timely manner.
Supports training efforts to ensure medical device and combination product quality concepts and processes are understood throughout the site.
Supports engineering efforts for processing change requests involving potential impact to device design and/or DHF document impact.
Reviews PQS requirements related to Medical Device and Combination products and assesses impact to Quality Management System.
Ensures MDCP reference tools, job aids, and other ancillary supporting documents are updated with current information and communicated to appropriate users/stakeholders.
Qualifications Must Have Applicant must have eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor’s degree with at least three years of experience; OR a Master’s degree with more than one year of experience.
Candidates with related advanced science degrees and relevant experience may also be considered as follows: PhD with at least 1 year of experience.
Must be detail oriented with expert knowledge of 21 CFR Part 4, 21 CFR Part 820, ISO 13485 pertaining to CAPA, data analysis, and management responsibilities.
The successful candidate will have demonstrated ability in developing scientific reasoning and problem solving with minimal coaching, as well as excellent written and oral communication skills.
They will be able to engage colleagues globally and will do so in a manner that recognizes the organizational and cultural differences that may exist between their partners around the world.
They will also have excellent negotiation skills and will be able to frequently resolve issues with a focus on regulatory compliance.
They will have demonstrated skill in developing solutions and will do so with a flexible approach to the development of options.
Understanding Quality Management Systems in a GMP regulated environment.
Experience with statistical analysis and analyzing quality data with software (i.
e.
Minitab) for escalations.
Experience with internal audit programs and/or regulatory inspections is preferred.
Preferred Minimum 5 years of experience in a Medical Device Regulated Environment.
Minimum 5 years of experience in a Quality Assurance role.
Expertise in FDA regulations and ISO Quality requirements.
Experience facilitating and coordinating compliant device site governance processes.
5 years of successful and demonstrated device quality management system remediation to US regulations.
ORGANIZATIONAL RELATIONSHIPS The successful colleague will interface with numerous groups within the site, including QO, Continuous Improvement, Manufacturing, Procurement, Engineering, and site leadership.
PHYSICAL/MENTAL REQUIREMENTS Office environment primarily, with regular entry into production areas.
Must be able to work independently, with minimal guidance, and consistently produce quality work.
Must be able to work in a team environment within own team and interdepartmental teams.
Must have effective written and oral communication skills.
Must be able to multi-task, meet deadlines, and maintain a high standard of work even with short timelines.
Must have the ability to handle complex and detailed situations.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Hybrid Relocation support available Work Location Assignment: Flexible Last Day To Apply: March 7th, 2024.
The annual base salary for this position ranges from $78,000.
00 to $130,000.
00.
In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.
0% of the base salary.
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 #LI-PFE