Senior Quality Engineer Design Quality-Design Lifecycle Management
Senior Quality Engineer Design Quality-Design Lifecycle Management
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Salary Not Disclosed
1 Vacancy
Job Description
Purpose:
Responsible for representing QA on crossfunctional 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. The role performs a variety of tasks related to monitoring of the Quality Management System pursuant to regulatory and statutory requirements (21 CFR 820 MDR 2017/745 EN ISO 13485).
Responsibilities:
- Perform QA activities related to Combination Product and Medical Device Development:
- Ensure compliance with company policies and procedures.
- Perform design control and risk management activities according to AbbVies Quality System
- Partner within Quality and Operations to ensure design control documentation (Risk Management Traceability/Linkages) & design change control requirements are met
- Perform 3rd party supplier management activities such as review 3rd party design control activities
- Support the creation of regulatory submission documentation
- Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
- Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.
- Actively monitor effectiveness of processes and quality of project work propose and execute quality/process improvements. Write/review policies/processes/procedures and related documents
- Apply knowledge of global regulations guidances and Corporate and Function standards.
- Lead/assist in the preparation of and support regulatory agency and internal audits.
- Conduct lead or participate in investigations and review boards for CAPAs NCRs Observations etc.
- Participate in departmental Change Control activities utilizing Design Control knowledge to perform design change impact assessments.
- Review and approve changes relevant to the department
- Support interactions with regulatory authorities (e.g. Notified Body audits)
- Write and revise procedures forms and other documents as needed
Work with the crossfunctional team to drive change and continuous improvement
Qualifications :
Qualifications:
- Bachelors degree preferably in Biology Chemistry or Engineering
- 6 years of overall experience in Manufacturing Quality or Engineering
- Strong understanding of regulations and standards affecting combination products and medical devices.
- Working knowledge of 21 CFR 820 EU MDR 2017/745 ISO 13485 and ISO 14971
- Working knowledge of Design Control per 21 CFR 820.30
- Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills
- Product development experience (e.g. approaches for definition of requirements and specification setting for verification and validation). Practical experience in design control and risk management.
- Effective use of oral and written communication skills to clearly communicate the quality position and the actions necessary to resolve issues
- Interpersonal team leadership and negotiation skills to handle conflicting priorities
- Strong oral and written communication skills excellent interpersonal and crosscultural skills required.
- Capable of clearly presenting and justifying quality requirements to management
Accreditation by a professional body is highly desirable. Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).
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 shortterm 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 serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
