Medical Device Quality Assurance Senior Engineer

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.

WHAT YOU WILL ACHIEVE

You will be a member of Pfizer’s dedicated and highly effective quality assurance team helping to drive quality and deliver products that impact patients lives. You will push the development teams to deliver the highest quality products and solutions. You will work with the product development team focused on medical devices used in combination products.

ROLE SUMMARY

The Quality Assurance Senior Associate will work with the product development teams focusing on medical devices and medical device combination products. The Senior Associate will utilize their engineering/technical skills and knowledge assisting in the quality review of the Design History File (DHF) and Risk Management File (RMF) to ensure compliance to CFR 820.30 Design Controls, ISO 14971 Risk Management, and other applicable regulatory requirements for a medical device or for the device constituent and drug-device interfaces of combination products. The Senior Associate will be an advocate for quality who collaborates with other functional teams reviewing design control deliverables to ensure the developed products are safe and effective.

ROLE RESPONSIBILITIES

As a Senior Associate you will be part of the Medical Device and Combination Products (MDCP) Quality Assurance team within the PGS organization and provide quality support to Pharmaceutical Sciences and Global Technical Engineering (GTE) for the development & commercialization of Medical Devices and Combination Products. Your knowledge and skills will contribute towards the goals and objectives of the team within the requirements of the Pfizer quality system and associated regulatory requirements. You are expected to be a self-directed professional who can identify issues, communicate effectively to all levels within the organization, have a focus on quality, help in completing critical deliverables, facilitate in explaining difficult issues, and establish consensus with team members.

Responsibilities include but not limited to:

• Act as the quality assurance resource supporting new product development at Cambridge, UK (Devices Centre of Excellence), Andover/St Louis (Drug Product Design and Development) and Lake Forest (Device and Combination Products)
• Ensure new product development documents (design control and risk management) conform to established requirements and standards including 21 CFR 820, ISO 13485, IEC 62366, IEC62304, ISO 14971, and MDCP procedures
• Provide guidance, recommendations, and support in the authoring of implementation plans for adherence to new regulations, standards, and procedures.
• Provide support for audits and inspections by FDA, notified bodies, competent authorities, and other third parties.
• Demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations, Good Manufacturing Practices (cGMP), Good Documentation Practices (cGDP), and standard problem-solving techniques
• Well versed in quality investigation techniques. Assist in investigating deviations related to laboratory, verification, validation, or manufacturing activities
• Reviews and approves project related documentation including protocols, validations, complaint/non-conformance records, supplier assessments, and quality agreements.
• Interact with functional departments, suppliers, and experts to implement quality goals
• Apply ISO and QSR requirements to processes and procedures internally and externally

BASIC QUALIFICATIONS:

• Bachelor’s Degree or equivalent in engineering, science, or related discipline.
• 3+ years’ experience working in a Quality Assurance, the pharmaceutical industry, GMP manufacturing, or Medical Device industry.
• Technical understanding of 21 CFR 820, ISO 13485, and ISO 14971.
• Understanding of verification and design validation activities related to new product development.
• Experience in complaint investigations of medical devices or medical device combination products.
• Knowledge and application of device root cause analysis methodology and device CAPA requirements
• Demonstrated influencing and negotiating skills. High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgement

PREFERRED QUALIFICATIONS:

• ASQ CQE Certification (Optional)
• ISO 13485 Lead Auditor Certification (Optional)

SKILLS:

• Strong leadership, negotiation, interpersonal, communication, and facilitation skills
• Proven ability to succeed in a fast-paced, challenging, and complex environment.
• Comfortable working and making risk-based decisions, interpreting regulations, and explaining device quality system principles
• Proven problem-solving skills
• Ability to lead and deliver in a matrix environment
• Prior experience in working with external vendors and suppliers

PHYSICAL/MENTAL REQUIREMENTS

The successful candidate will be capable of independent problem solving and working with minimal direction under most circumstances. The successful candidate will also possess strong oral and written communication skills. Strong analytical and computer skills are required.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

The role may include frequent business travel across Pharmaceutical Sciences, vendors, and suppliers.

Work Location Assignment:Remote

Last Date to Apply: September 28 2022

Relocation assistance may be available based on business needs and/or eligibility.

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.