Quality Engineer, Design Assurance - Contract - TalentBurst, Inc.
Woburn, MA
About the Job
Title: Quality Engineer, Design Assurance
Location: Woburn, MA
Duration: 12+ Months
Job Summary:
We are seeking a skilled Design Assurance Engineer or Systems Engineer to join our team as a contractor for a 9-12 month term. Reporting to the Director of QA/RA, the Quality Engineer, Design Assurance will establish and organize 21CFR820.30 compliant Design History Files and IVDR Class A Technical Documentation for existing Covaris systems. The ideal candidate will be a self-motivated professional with a strong background in engineering and a commitment to excellence . This position will require candidate to be on site at least 3 days a week. The contractor operates in support of ISO 13485 certification and IVDR remediation.
Responsibilities include:
Essential Responsibilities: The employee may be required to perform all or a combination of the following essential responsibilities as determined by business necessity.
Non-Essential Responsibilities: The employee may be required to perform other non-essential functions, follow any other job-related instructions, and perform any other job-related duties requested by their supervisor.
Qualifications:
Note: The candidate must be a contractor and possess flexibility in their schedule to accommodate the standardized 40-hour workweek at the Woburn, MA corporate office.
#TB_EN
Location: Woburn, MA
Duration: 12+ Months
Job Summary:
We are seeking a skilled Design Assurance Engineer or Systems Engineer to join our team as a contractor for a 9-12 month term. Reporting to the Director of QA/RA, the Quality Engineer, Design Assurance will establish and organize 21CFR820.30 compliant Design History Files and IVDR Class A Technical Documentation for existing Covaris systems. The ideal candidate will be a self-motivated professional with a strong background in engineering and a commitment to excellence . This position will require candidate to be on site at least 3 days a week. The contractor operates in support of ISO 13485 certification and IVDR remediation.
Responsibilities include:
- Actively support product development initiatives with Design Assurance services including authoring documentation.
- Support Product Development with quality documentation as needed.
- Escalate potential issues that could impact compliance.
- Establish technical documentation in support of IVDR Class A systems.
- Establish System Level Design History Files
- Identify and fill gaps in historical records.
- Perform design verification and validation activities as needed.
- Establish system level risk management files.
- Perform other duties as assigned.
Essential Responsibilities: The employee may be required to perform all or a combination of the following essential responsibilities as determined by business necessity.
- Conduct investigations of identified problems with existing products in the field and production. Use Complaints, NCMR, CAPA, and DCO processes to modify product design or manufacturing procedures as required.
- Administer and improve quality processes, with a focus on Lean process management.
- Assist manufacturing and product development with documentation, guidance, and execution of design verification/validation and process validation.
Non-Essential Responsibilities: The employee may be required to perform other non-essential functions, follow any other job-related instructions, and perform any other job-related duties requested by their supervisor.
Qualifications:
- Bachelor's degree (minimum) in an engineering, technical or scientific discipline or equivalent.
- Pragmatic, entrepreneurial personality and strong self-starter. Continually strives to improve.
- A minimum of 5+ years of working experience in Design Assurance or Systems Engineering.
- Excellent technical writing skills
- Understand design controls, change controls, phase gated product development processes.
- Demonstrated track record with 21 CFR 820.30, ISO 13485, the IVDR (Class A) and ISO 14971.
- Demonstrated track record implementing risk management files.
- Able to create multi-source reports, trends, and interpret data with minimal oversight.
- Communicates effectively both verbally and in writing
- Acts decisively with Integrity and Kindness.
Note: The candidate must be a contractor and possess flexibility in their schedule to accommodate the standardized 40-hour workweek at the Woburn, MA corporate office.
#TB_EN
Source : TalentBurst, Inc.