Quality Compliance Engineer
Pfizer, S.A. de C.V, Rochester, MI, United States
Quality Compliance Engineer
The Quality Compliance Engineer ensures adherence to regulatory requirements, company quality systems, and current Good Manufacturing Practices (cGMP). The role leads continuous improvement initiatives, drives quality‑related projects, and partners cross‑functionally to strengthen compliance, efficiency, and inspection readiness across the site.
Responsibilities
Lead and support continuous improvement initiatives focused on strengthening quality systems and reducing repeat deviations.
Apply root cause analysis tools (e.g., 5 Whys, fishbone, data trending) to identify systemic issues and drive sustainable solutions.
Partner with cross‑functional teams to simplify processes, improve documentation quality, and enhance compliance efficiency.
Support development and monitoring of quality metrics to identify trends, risks, and opportunities for improvement.
Provide quality oversight and guidance for engineering activities such as equipment qualification, process validation, and facility or utility changes.
Participate in risk management activities (e.g., FMEA, hazard analysis) to support robust design and compliant execution.
Partner with Manufacturing, Engineering, Validation, Supply Chain, and Quality teams to ensure compliant execution of site activities.
Qualifications
Education and experience: Bachelor’s degree with at least 4 years of experience; OR Master’s degree with at least 2 years; OR PhD with 0+ years; OR Associate’s degree with 8 years; OR high‑school diploma (or equivalent) with 10 years.
Experience in Quality Assurance, Quality Compliance, or Engineering support roles.
Experience leading continuous improvement or remediation initiatives.
Familiarity with root cause analysis, risk management, and quality metrics.
Experience supporting regulatory inspections and audits.
Knowledge of electronic quality management systems (eQMS).
Preferred Qualifications
Continuous improvement mindset.
Project planning and execution skills.
Regulatory and compliance expertise.
Problem‑solving and data‑driven decision making.
Cross‑functional collaboration and influence.
Attention to detail with a focus on sustainability and effectiveness.
Physical/Mental Requirements
Ability to work in manufacturing and controlled environments, including gowning requirements. Must not be allergic to penicillin.
Work Schedule, Travel, and Environment
1st shift position. Occasional off‑shift or weekend support may be required to support operations, projects, or inspections.
Benefits
Comprehensive benefits package including 401(k) plan with Pfizer matching contributions, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits covering medical, prescription drug, dental, and vision.
Compensation
The annual base salary ranges from $99,200.00 to $165,400.00. The position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of base salary and eligibility for share‑based long‑term incentive program.
Relocation Assistance
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to healthcare providers as required by federal and state transparency laws. Licensed physicians who incur recruiting expenses that Pfizer reimburses may have those expenses reported under the Sunshine Act.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, disability, or veteran status. Pfizer complies with all applicable laws governing nondiscrimination and work authorization requirements. Pfizer is an E‑Verify employer. This position requires permanent work authorization in the United States.
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The Quality Compliance Engineer ensures adherence to regulatory requirements, company quality systems, and current Good Manufacturing Practices (cGMP). The role leads continuous improvement initiatives, drives quality‑related projects, and partners cross‑functionally to strengthen compliance, efficiency, and inspection readiness across the site.
Responsibilities
Lead and support continuous improvement initiatives focused on strengthening quality systems and reducing repeat deviations.
Apply root cause analysis tools (e.g., 5 Whys, fishbone, data trending) to identify systemic issues and drive sustainable solutions.
Partner with cross‑functional teams to simplify processes, improve documentation quality, and enhance compliance efficiency.
Support development and monitoring of quality metrics to identify trends, risks, and opportunities for improvement.
Provide quality oversight and guidance for engineering activities such as equipment qualification, process validation, and facility or utility changes.
Participate in risk management activities (e.g., FMEA, hazard analysis) to support robust design and compliant execution.
Partner with Manufacturing, Engineering, Validation, Supply Chain, and Quality teams to ensure compliant execution of site activities.
Qualifications
Education and experience: Bachelor’s degree with at least 4 years of experience; OR Master’s degree with at least 2 years; OR PhD with 0+ years; OR Associate’s degree with 8 years; OR high‑school diploma (or equivalent) with 10 years.
Experience in Quality Assurance, Quality Compliance, or Engineering support roles.
Experience leading continuous improvement or remediation initiatives.
Familiarity with root cause analysis, risk management, and quality metrics.
Experience supporting regulatory inspections and audits.
Knowledge of electronic quality management systems (eQMS).
Preferred Qualifications
Continuous improvement mindset.
Project planning and execution skills.
Regulatory and compliance expertise.
Problem‑solving and data‑driven decision making.
Cross‑functional collaboration and influence.
Attention to detail with a focus on sustainability and effectiveness.
Physical/Mental Requirements
Ability to work in manufacturing and controlled environments, including gowning requirements. Must not be allergic to penicillin.
Work Schedule, Travel, and Environment
1st shift position. Occasional off‑shift or weekend support may be required to support operations, projects, or inspections.
Benefits
Comprehensive benefits package including 401(k) plan with Pfizer matching contributions, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits covering medical, prescription drug, dental, and vision.
Compensation
The annual base salary ranges from $99,200.00 to $165,400.00. The position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of base salary and eligibility for share‑based long‑term incentive program.
Relocation Assistance
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to healthcare providers as required by federal and state transparency laws. Licensed physicians who incur recruiting expenses that Pfizer reimburses may have those expenses reported under the Sunshine Act.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, disability, or veteran status. Pfizer complies with all applicable laws governing nondiscrimination and work authorization requirements. Pfizer is an E‑Verify employer. This position requires permanent work authorization in the United States.
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