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Quality Engineer

Company: Actalent
Location: Sterling
Posted on: September 17, 2022

Job Description:

Description:Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Working within the Quality Department, under general supervision, the Quality Engineer (CAPA) will ensure compliance to CAPA processes and procedures and is responsible for, but not limited to:1. Formulates procedures, specifications, and standards for products and processes.2. Develops and implements corrective/preventative action plans.3. Initiating CAPA Risk Assessments, timely review and approval of NCs and CAPAs ensuring completeness, accuracy, and effectivity.4. Facilitating and guiding cross-functional teams through all stages of the NC / CAPA process.5. Implementing and executing CAPA Review Board forums. 6. Establishing site NC/CAPA KPIs and monitoring KPIs to ensure compliance to global requirements and to ensure metrics are achieved and provide detailed updates to management.7. Monitoring customer feedback, complaints, process non-conformances, and surveillance audits and identify opportunities for continuous improvement. 8. Participating in cross-functional project teams in areas of continuous improvement, non-conformances and CAPAs.9. CAPA SME in internal and third-party compliance audits.Qualifications:1. BS degree or at least 1-3 years of working experience in quality and/or regulatory in a biotech environment (medical device, pharma, life sciences).2. Certified Quality Engineer (CQE) and medical device experience preferred.3. Hands on experience working through all phases of the CAPA process.4. Ability to communicate effectively (both written and verbal) - with various levels within the organization.5. Hands on experience delivering timely and accurate QMS documents.6. Knowledgeable in GMP, GDP, ISO 13485, and 21 CFR 820 requirements.7. Developed problem solving skills and analytical skills required.8. Professional certification in a quality subject matter (e.g., MS, CQE, CQA, Six Sigma), preferred9. Knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment, preferred.Skills:medical device, Reporting, Quality control, Quality assurance, lean manufacturing, lean six sigma, validation testing, Process engineering, Improvement plan, Communication and people skills, Documentation writing, Validation, regulatory complianceTop Skills Details:medical device, Reporting, Quality control, Quality assurance, lean manufacturingAdditional Skills & Qualifications:1. Biomedical or other engineering /scientific degree with at least 3-5 years of hands-on Quality Engineering and/or Quality Assurance experience in a medical device Company required.2. Working knowledge and manufacturing applicability of ISO 13485 and 21 CFR principles and requirements for medical device manufacturers.3. Working experience leading complaints/failures investigations through closure while driving improvement initiatives.4. Expert hands-on experience with root cause investigations.5. Computer skills, proficiency with Microsoft Office suite (specifically Word and Excel)6. Strong organizational skills7. Strong oral and written communication skills8. Excellent attention to detail and proven ability to work in a fast-paced environment9. Ability to work well with a team10. Self-motivated to resolve issues, identify areas that need attention and either resolve or raise issue concerns as appropriateMust Haves: Med device quality industry experience, preferably in manufacturing, enhancement in existing in new products. Med device experience is a must. FDA and regulated industry experience is a must; Degreed within engineering, any optical experience a plus but not requiredExperience Level:Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Sterling , Quality Engineer, Engineering , Sterling, Virginia

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