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