The role of the Quality Engineer is to assist in the planning,
executing, and finalizing projects according to strict deadlines
and within budget. Specific functional areas include, but not
limited to, preparation and execution of protocols, perform
validation activities related to equipment, process, software and
measurement tools/methods (Gauge R&R). The Quality Engineer
will also assist defining the projects objectives and oversees
quality control throughout its life cycle.
The individual must be capable of working independently and in a
team setting supporting the Dartmouth Quality and Operations
groups. Major responsibilities include:
Proficient in writing and executing validation protocols and
Investigate and resolve incoming, in-process, and final
inspection product problems to reduce/eliminate scrap and
Analyze process statistics and conduct efficiency studies
Recommend and implement process improvements and
Executes on-site transfer projects and product scale-up
Create formal work instructions and process procedures as
determined internally or via customer requirements.
Establish production/process standards
Implement real-time Statistical Process Control (SPC) as
Optimizes manufacturing processes to provide sustainable gains
in cost effectiveness and product performance through statistical
analysis, designed experiments, and procedural changes.
Drive quality improvements by increasing internal competencies
in process control / verification and validation studies, root
cause analysis, process failure mode and effects analysis (PFMEA),
and the use of other applicable process tools.
Work with suppliers, customers and internal cross-functional
teams to resolve technical/quality issues and develop effective and
Provide leadership and general Quality Engineering support to
incoming, in-process & final product inspection.
Provide leadership to drive quality and efficiency improvements
in manufacturing and inspection processes.
Evaluate and update critical-to-quality process parameters and
update specifications and protocols as appropriate.
Additional duties and responsibilities as required.
Level of Skill, Education and Experience:
A minimum B.S. in an engineering discipline, preferably
mechanical or manufacturing
engineering with 5+ years of related experience in a medical
Excellent written and oral communication skills.
Working knowledge and understanding of ISO 13485, FDA Quality
System Regulation (QSR), and
other applicable Quality and Regulatory requirements.
A proven track record of working in a fast paced manufacturing
environment while managing
Experience using a variety of inspection equipment and basic
Ability to identify capital and inspection equipment needs and
fulfill requirements for
Identify capital equipment
Strong engineering skills with working knowledge of the
Process validation and verification activities. (IQ, OQ, PQ,
Risk analysis techniques, which include PFMEA (Process Failure
Modes and Effects Analysis).
Manufacturing Control Plans and Flow Plans.
Blue print & GD&T reading
Problem solving techniques including root cause analysis, and
cause and effect analysis.
Proficiency with Microsoft Office suite (Word, Excel, Project,
PowerPoint) and statistical
tools (i.e.- Minitab, etc).
Demonstrated Process Control application with Lean & Six Sigma
Black Belt certification
Knowledge of Design Of Experiments (DOE) desired
Experience in a Medical Device or other regulated environment is
Hands-on experience in manufacturing, quality & process
Minimal travel required (<10%).
Tegra Medical is an Equal Opportunity Employer