Quality Engineer 4
Posted on :
10-06-2024
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Job Description
Overview:
Tekwissen Group is a workforce management provider throughout the USA and many other countries in the world. The below client is with one of our client which is a leading global medical technology company. It offers a wide range of diagnostic imaging and laboratory diagnostics as well as advanced therapies and digital health services. Its solutions span from prevention and early detection to diagnosis treatment and followup care empowering healthcare providers worldwide.
Job Title: Quality Engineer 4
Location: Newton MA 02466
Duration: 3 Months
Job Type: Contract
Work Type: Onsite
Job Description:
Primary Responsibilities:
- Interface with all departments in the organization in matters related to the quality system compliance.
- Propose lead initiate and followup on Corrective Action and Preventive Actions (CAPA).
- Support the Internal Audit program and provide backroom support for External
- Audits (Regulatory Notified Body and Customer).
- Assist in the management of a Calibration and Preventative Maintenance program.
- Disposition nonconforming material (NCMR).
- Support product complaint investigations leading to root cause determination.
- Support updates to the Risk Management File (FMEA Hazard Analysis Post Market Surveillance Reports etc.).
- Review and as needed update QMS procedures (SOPs Work Instructions Forms) to reflect latest industry standards guidance documents and best practices.
- Support the completion of validation protocols and test plans (IQ OQ PQ test method and inspection method qualification).
- As appropriate assist in supplier qualification activities (initial assessments and categorization).
- Other duties as assigned by manager.
Qualifications:
- Minimum 4year degree in Engineering/BioMedical Engineering or Life Sciences (in lieu of degree additional work experience will be considered.)
- 7 to 10 years of experience as a Quality Engineer in the medical device industry; QMSR/ MDD/MDR and ISO13485 experience required.
- Notified Body/Regulatory Audit experience; Certified Quality Auditor (CQA) certificate is preferred.
- Must have experience in CAPA NCMR Internal/External Audits calibration/preventive maintenance activities risk management activities and design controls.
- Technical skills including the ability to read technical specifications and interpret industry standards and regulations.
- Effective and professional communication skills; Internal (engineering operations R&D etc.) and external (customers auditors and suppliers) required.
- Effective time/task management skills; excel working in a fastpaced environment.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Employment Type
Full Time
Key Skills
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