Quality Engineer

Company: Synectics Inc.
Location: Saint Paul
Posted on: February 21, 2021

Job Description:

Assures products, processes, and quality records conform to quality standards and establishes compliance with the quality system.Developing and maintaining quality engineering methodologies and providing quality engineering support within quality system/services support. Maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs.Provide site administration of the CAPA program and support process owners in completing CAPAs and related business items.Support and guide the Corrective Action Review Board and Users regarding the CAPA process, CAPA record content, and CAPA software.Support the development, implementation and continuous improvement of Quality System CAPA procedures, CAPA software, and CAPA training.Participate in the completion of CAPA projects, assuring compliance, quality and timeliness of records.Ensure implementation, and effectiveness verification of CAPA and participate in remediation of legacy CAPA files.Responsible for assisting with metrics and reporting on regular basis in accordance with established procedures.Support team in the delivery and oversight of CAPA training program.Ensure that CAPA records are complete and they contain accurate links and references to other Quality processes such as Change Management, Non-Conformance, and Complaint Handling.Manage the archival and handling of scanned CAPA records.Critical Review of documents. Provide support as SME in a guidance perspective as they own and navigate CAPA processTesting regulations and standardsImplementing and maintaining the effectiveness of the quality system.Support Global CAPA team with training, CAPA oversight, and CAPA deliverables.Support decision making and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems.Provides data and quality metrics that feed into quality investigations, management reviews, and ad hoc presentations. This data will be used as objective evidence to support decision making, to drive action, and in order to aid in the escalation of issues to Senior Management. Participate in meetings and communications for QA system information, concerns, and updates.Seeks out information with direction and able support other members of the organization on QA practices.Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental management Systems (EMS), and other regulatory requirements.Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.Qualifications:Bachelor level degree in Engineering, Technical Field, or equivalent2-4 years technical experience Extroverted personality Can support or lead efforts of project or processes in a group setting Experience owning CAPA's required - able to articulate CAPAs Root cause analysis/problem solving training and experience Great with Excel and manipulation of data; good with numbers Advanced computer skills, including statistical/data analysis and report writing skills Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, and attention to detail. Ability to maintain regular and predictable attendance. Demonstrated writing and communication skills are required for this position. A thorough understanding of the ISO/QSRs and can apply that knowledge with an understanding of business operations to achieve regulatory compliance is needed. Able to explain audit results and influence other's understandings of audit observations in a tactful and professional mannerPreferred Qualifications:Advanced Degree Desired Previous Quality assurance/engineering experience Prior medical device experience CAPA Background Knowledge of CatsWeb or Epic tools Experience working in a broader enterprise/cross-division business unit modelExperience in assessing the weight of evidence associated with a claim/hypothesis/assertion

Keywords: Synectics Inc., St. Paul , Quality Engineer, Engineering , Saint Paul, Minnesota