Title: Senior Quality Engineer
Duration: 12+ months with possible extension
Location: Wallingford CT
The responsibility of this position will be to maintain and improve Quality Engineering Programs and Quality System activities to enhance the quality of products and services we supply. The QE will be knowledgeable in all areas of the Quality Management Systems. In addition to the Quality Program/System responsibilities, QE is expected to support new product development and sustaining engineering directly as part of a project team or indirectly for peripheral support needs. This position supports and guides product development teams through the design life cycle and transfer of the product into manufacturing and post manufacturing support ensuring compliance with the Quality System Regulations, 21 CFR Part 820, ISO 13485 and other international standards. In addition, the successful candidate will be responsible for post market activities associated with that product line including any sustaining activities and contract manufacturing production issues. The Senior Quality Engineer is viewed as an active and valued contributor to design, risk analysis, project plan, process validation, and design transfer activities. The Senior Quality Engineer is required to balance business objectives and quality requirements to determine readiness of projects to proceed to the next phase. Conduct safety, efficacy and hazard analysis, FMEAs, FTAs and FTA Criticality and help to drive improvement in Quality Metrics such as product development cycle time. The Sr. QE will conduct internal quality system audits and external audits, lead process auditors in process audits and record audits, review production line failures and corrective actions, review and investigate customer complaints conduct quality system training, write and review procedures for quality assurance and other functional elements of the quality system and resolve corrective and preventive action (CAPA) issues. The Sr. QE will also work with suppliers to resolve product/process issues, monitor supplier performance and conduct supplier audits.
Demonstrated understanding of, and ability to interpret, regulations and guidelines governing medical device development & testing, including CFRs, ISO, MDD, and other international/regulatory standards.
Excellent technical writing, communication, and organization skills and working within FDA or similarly regulated environment, required.
Plans and manages assignments of significant technical scope
Perform technical and non-technical product failure evaluations documenting and effectively communicating root cause findings.
Skilled at performing reviews, system/product failure analysis, First Article Inspections (FAI), and Incoming Inspections, as required.
Skilled in creating, interpreting and modifying component/schematic drawings.
Support new product development and product engineering by generating and/or processing key documents which may include quality plans, design review, risk and hazard analysis, verification and validation plans, product and process validation.
Conducts internal quality system audits and external audits.
Willingness to work as part of a team and strong verbal and written communication skills are essential.
Able to work independently and complete multiple assignments on time.
Skilled with applying Quality Tools.
Skilled in Internal Auditing and Lead Auditor duties.
Capable of making technical calculations involving the use of engineering and mathematical formulas such as finding standard deviations.
Skilled at trouble shooting and problem solving.
Skilled at interacting directly with suppliers, operation/manufacturing services and engineering support services.
Understanding Software Validation is preferred.
Skilled with Word or other word processing software, and SAP (or related) navigation, required. Experiences with multiple statistical/QS software packages are a plus.
Write routine procedures and reports and make necessary corrections.
Write and update Quality Inspection Plans.
Candidate must have a minimum of 7 years experience working in a Quality Engineering role.
Experience in an ISO registered and regulated industry is required.
BSEE preferred, BS Engineering field required
Please send me your confirmation that no one else has contacted you for this position apart from APN Team.
Thanks and Regards,
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560