QA Manager, Combination Products and Medical Devices
QA Manager, Combination Products and Medical Devices
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Salary Not Disclosed
1 Vacancy
Job Description
Purpose:
Describe the primary goals objectives or functions or outputs of this position.
Primary responsible for representing QA on cross-functional combination product and medical device development teams and executing Quality System requirements to ensure products developed manufactured tested and procured and data generated are compliant with worldwide Combination Product and Medical Device Regulations.
Responsibilities:
- Assure proper integration and support of device regulations drug regulations and as appropriate biologics regulations. Responsible for compliance with company policies and procedures.
- Perform design control activities: Mentor/lead product team members through the design process providing guidance to assure optimal approach. Work closely with research organization to ensure potential product issues are identified and addressed in the design. Assure robust product vs. customer requirements. Ensure interfaces to drug development where appropriate.
- Ensure design control documentation (Traceability/Linkages) & design change control requirements are met. Assess the impact of a change on the safety efficacy of the combination product/device. Analyze and justify the impact on cumulative changes
- Perform 3rd party supplier management activities such as review and approval of 3rd party design control activities assess supplier changes and ensure of appropriate balance between internal oversight actions and supplier controls provide input to quality agreements perform relationship development and visit supplier sites. Support supplier audits as required. Partner with Third Party Vendors/Manufacturers/Laboratories to ensure that combination products/devices are in compliance with internal and Regulatory Agency standards
- Risk Management: Global collaboration with R&D and Commercial Operations functions to identify and mitigate product risks to develop robust combination products and medical devices
- Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation
- Guide project development as team member in global and local product development teams for Combination Products to proactively and appropriately address quality-related issues. Advise internal business partners with regard to medical device/combination product regulations
- Provide consultation & training on specific QA expertise to internal and cross-functional groups
- Foster close global collaboration with R&D and Operations functions to identify and mitigate product risks to develop robust combination products and devices. Perform risk assessment of changes on safety and efficacy of Combination Products. Utilize risk control tools such as FMEA
- Support the preparation of regulatory inspections and internal audits and represent GMP QA in inspections and audits as SME
This is a hybrid role based at our Lake County IL headquarters.
Qualifications :
- Bachelors degree is required; preferably in sciences engineering or other technical/scientific area.
- Minimum 6 years of industry experience in Quality Assurance Development or healthcare related field. Medical device experience required. Combination Product and 3rd party supplier management experience preferred. Less experience considered with advanced degree.
- Understanding of regulations and standards affecting combination products and medical devices required. Must have leadership skills and have been seen to take a position on Quality issues and standards and must be capable of clearly and logically justifying such positions.
- Sound technical understanding of product development (e.g. approaches for definition of requirements and specification setting for verification and validation) and/or practical experience in design control.
- Well-versed in risk management methodologies and their application.
- Able to take the initiative to identify and implement new approaches to resolve problems able to challenge scientific arguments - strong analytical approach to identify problem areas and effective solutions.
- Work independently and in a global team environment and with all levels of personnel within the organization.
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.
This job is eligible to participate in our long-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:
No
Employment Type :
Full-time
Employment Type
Full-time
