Job Description
Quality Engineer
Position Overview:
This position will support manufacturing quality operations in a dynamic, fast-paced, medical device manufacturing environment. This environment includes the manufacture, inspection, and test of devices for design verification, design validation, and commercial production.
Responsibilities:
Qualifications and Skills:
Education: Bachelors degree or equivalent experience in Industrial, Mechanical or related engineering / life sciences related discipline.
Position Overview:
This position will support manufacturing quality operations in a dynamic, fast-paced, medical device manufacturing environment. This environment includes the manufacture, inspection, and test of devices for design verification, design validation, and commercial production.
Responsibilities:
- Work cooperatively with other team members and in compliance with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 to transition products from development to manufacturing.
- Use experience within medical devices, to provide guidance and assistance in the development of new production processes
- Drive the development, implementation, and approval of PFMEAs and control plans.
- Develop inspection processes and sampling plans according to the risk level of the components, material and devices
- Use experience with engineering and technology to ensure compliance with applicable standards and regulations.
- Ensure all product, processes, and components are within specifications and work with internal team and with customers to resolve any nonconformance issues
- Facilitate the development, implementation, and approval of Device Master Records and Device History Records.
- Review existing procedures and for continuous improvement and improved workflow
- Lead investigations resulting in root cause and corrective actions through use of data analysis, inductive and deductive reasoning, and problem solving skills.
- Use critical thinking and deductive reasoning to make risk based decisions.
- Develop and approve technical documents to plan work, such as Master Validation Plans, Quality Plans, and Qualification Protocols; support execution of work product.
- Collect and evaluate data, lead system and process improvements using six sigma tools
- Provide reliability and statistical analysis of data for investigations, qualifications, test method validations and other Quality related activities.
- Participate in ISO 13485 audits and assist in FDA and other regulatory inspections Will use Microsoft Office software (Word, Outlook, Excel).
Qualifications and Skills:
- 3 + years of experience in occupation related to Quality Control of medical devices.
- Experience with compliance, with applicable standards and regulations such as 21 CFR 820 and ISO 13485:2016 is required.
- Experience participating in internal and external audits.
Education: Bachelors degree or equivalent experience in Industrial, Mechanical or related engineering / life sciences related discipline.
Numbers & Facts
| Location | Manchester, Nh, NH |
| Industry | Staffing/Employment Agencies |
| Company Size | 500 to 999 employees |
| Year Founded | 1999 |
| Website | https://www.csetalent.com/ |
About Company
Connexion is an award-winning professional staffing firm that strives to be the unrivaled staffing solution for job seekers by expertly connecting talent with opportunity. Over the last 20 years Connexion has built the most admired team of staffing experts in the industry. We give back, change lives and offer unconditional support to the candidates we represent.
Put Connexion's 20 years of experience to work for you! Our professionals have unrivaled relationships and contacts with the hiring managers, human resources team and decision makers at the most desirable companies to work for.
Don't let your resume get lost in an inbox, Connexion's recruiting team will advocate on your behalf to get you the job you want
Skills
- Biologyunmatched
- Code of Federal Regulationsunmatched
- Continuous Improvementunmatched
- Corrective Actionunmatched
- Data Analysisunmatched
- Data Collectionunmatched
- Deductive Reasoningunmatched
- Design Verificationunmatched
- Documentation Planunmatched
- External Auditunmatched
- FDA Requirementsunmatched
- ISO (International Organization for Standardization)unmatched
- Inductive Logicunmatched
- Internal Auditunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing Operationsunmatched
- Mechanical Engineeringunmatched
- Medical Equipmentunmatched
- Microsoft Excelunmatched
- Microsoft Officeunmatched
- Microsoft Outlookunmatched
- Microsoft Wordunmatched
- Operational Supportunmatched
- People Managementunmatched
- Problem Solving Skillsunmatched
- Process Developmentunmatched
- Process Improvementunmatched
- Product Supportunmatched
- Quality Assurance Methodologyunmatched
- Quality Controlunmatched
- Quality Engineeringunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Reliability Analysisunmatched
- Riskunmatched
- Root Cause Analysisunmatched
- Sampling Inspectionunmatched
- Six Sigmaunmatched
- Statisticsunmatched
- Team Playerunmatched
- Technical Writingunmatched
- Testingunmatched
- Validation Planunmatched
- Validation Testingunmatched
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