Senior Quality Engineer, Medical Device & Combination Product Quality Systems

North Chicago, IL - USA

Monthly Salary: Not Disclosed

Posted on: 5 hours ago

Vacancies: 1 Vacancy

Job Summary

Supports External Audits in Front Room or Back Room lead capacities demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits under MDSAP.
Conduct Internal Audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
Subject Matter Expert in both current and emerging regulations and standards impacting AbbVie medical device and combination products performing regulatory compliance assessments to support business decision-making.
Serves as Process Owner of QMS process of moderate complexity advancing process sustainment & improvement independently through effective project management.
Performs root cause investigation and corrective action planning in response to external and internal audit observations of moderate risk in collaboration with departmental process owners and subject matter experts.

Qualifications :

Bachelors degree preferably in engineering physical science (e.g. Chemistry) life science (e.g. Microbiology or Biology) or pharmacy and a minimum of 5 years of industry experience in a GXP regulated environment.
ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Quality Engineer (CQE) Six Sigma Certification or Project Management Professional (PMP) Certification.
The role operates with a moderate degree of autonomy & accountability making independent quality & compliance decisions timely and demonstrating the ability to manage multiple commitments with the support of other team members and management.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Employment Type :

Full-time

Supports External Audits in Front Room or Back Room lead capacities demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits under MDSAP.Conduct Internal Audits to assess the compliance of AbbVie quality management system...

Supports External Audits in Front Room or Back Room lead capacities demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits under MDSAP.
Conduct Internal Audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
Subject Matter Expert in both current and emerging regulations and standards impacting AbbVie medical device and combination products performing regulatory compliance assessments to support business decision-making.
Serves as Process Owner of QMS process of moderate complexity advancing process sustainment & improvement independently through effective project management.
Performs root cause investigation and corrective action planning in response to external and internal audit observations of moderate risk in collaboration with departmental process owners and subject matter experts.

Qualifications :

Bachelors degree preferably in engineering physical science (e.g. Chemistry) life science (e.g. Microbiology or Biology) or pharmacy and a minimum of 5 years of industry experience in a GXP regulated environment.
ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Quality Engineer (CQE) Six Sigma Certification or Project Management Professional (PMP) Certification.
The role operates with a moderate degree of autonomy & accountability making independent quality & compliance decisions timely and demonstrating the ability to manage multiple commitments with the support of other team members and management.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Employment Type :

Full-time

Key Skills

Quality Assurance
Six Sigma
Design Controls
FDA Regulations
ISO 9001
Minitab
Root cause Analysis
ISO 13485
Quality Systems
Quality Management
As9100
Manufacturing

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About Company

AbbVie

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more

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