Senior Quality Engineer - Medical Device Quality Systems

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

ROLE SUMMARY

Responsible for implementation of Kalamazoo site Quality Systems for Medical Device/Combination Products. Supports the creation, development and monitoring of Quality and Regulatory Compliance strategies for medical devices and combination products. Ensures inspection readiness and compliance with all applicable medical device and combination product regulations within the scope of the manufacturing site’s activities. This role is integral to continual improvement of processes, supports quality systems improvement efforts, and ensures timely escalation of issues.

ROLE RESPONSIBILITIES

• Supports the maintenance of Medical Device and Combination Products Quality Management Systems including remediation and continual improvement.
• Development, implementation and monitoring of Quality and Regulatory Compliance strategies for medical devices and combination products.
• Supports inspection readiness and compliance with all applicable medical device and combination product regulations within the scope of the manufacturing site’s activities.
• Provides SME support during Regulatory/Customer audits for products and Medical Devices including contributions to strategies to successfully respond to auditor concerns.
• Supports the evaluation of adequacy and compliance of the site Quality Management System against all applicable medical device/combination product regulations, company policies, and procedures.
• Contributes to quality systems improvement plans.
• Supports training efforts to ensure medical device and combination product quality concepts and processes are understood throughout the site.
• Supports device Management representative in preparation for device Management Review Meetings with timely inputs as required for leadership escalation.
• Provides support for MDCP Internal & External Audits and regulatory inspections, 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 technical execution of Design History File (DHF) enhancements / updates.
• Maintains knowledge of product and medical device filings to support inquiry responses from internal and external customers.
• Provides product knowledge and support for regulatory deficiency responses, regulatory annual reports, and the development of other regulatory submission packages.
• Performs data analysis for post market surveillance activities and for internal reports used to inform decisions and actions to drive improvement in regulatory compliance and customer satisfaction.
• Ensures device risk management files are updated regularly incorporating post-production information.
• Develops and monitors key metrics and provides input to device management reviews.
• Reviews and approves change requests for potential impact to device design and/or DHF document impact.
• Supports medical device or combination product issue investigations and assigned CAPAs.
• Reviews PQS requirements related to Medical Device and Combination products and assesses impact to Quality Management System.
• Effectively communicates complex technical issues to all levels of Management, including outside of Quality.
• Maintains positive working relationships with operations, engineering and above site groups. 

Qualifications

Must-Have

• Bachelor's degree in Chemistry, Biochemistry, Engineering, Life Science or other technical/scientific degree.
• Strong working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485:2016 requirements and related standards.
• 3 to 5 years experience in Medical Device or Combination Products Quality, Design Controls, Production, or related field.
• Understanding Quality Management Systems in a GMP regulated environment.
• Proven written and oral communication skills based on good Pfizer leader behaviors.
• Demonstrated proficiency in organizational and project management skills.
• Must be able to balance multiple priorities.
• Must be detail oriented with expert knowledge of regulatory requirements (e.g. US, EU and other key geographies).

Nice-to-Have

• Minimum 5 years of experience in a Medical Device Regulated Environment.
• Minimum 5 years of experience in a Quality Engineering, Quality Assurance role.
• Expertise in FDA regulations and ISO Quality requirements.
• Certification as Quality Engineer granted through American Society of Quality (ASQ).
• Experience facilitating and coordinating compliant device site governance processes.
• 5 years of successful and demonstrated device quality management system remediation to US regulations.

 
 

PHYSICAL/MENTAL REQUIREMENTS

• Office position with time in the production environment.
• First shift position.
• 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.

Other Job Details:

• Last Date to Apply for Job: January,17, 2022
• Eligible for Relocation Package: Yes
• Eligible for Employee Referral Bonus: Yes

#LI-PFE

Relocation support available

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Quality Assurance and Control

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