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Quality Engineer

Company: Tegra Medical
Location: Dartmouth
Posted on: June 7, 2021

Job Description:

Job Purpose:

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.

Essential Functions:

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 reports.

Investigate and resolve incoming, in-process, and final inspection product problems to reduce/eliminate scrap and rework

Analyze process statistics and conduct efficiency studies

Recommend and implement process improvements and modifications

Executes on-site transfer projects and product scale-up activities.

Create formal work instructions and process procedures as determined internally or via customer requirements.

Job Requirements:

Establish production/process standards

Implement real-time Statistical Process Control (SPC) as applicable

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 efficient solutions.

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 device environment.

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

multiple projects.

Experience using a variety of inspection equipment and basic metrology knowledge

Ability to identify capital and inspection equipment needs and fulfill requirements for

equipment procurement.

Identify capital equipment

Strong engineering skills with working knowledge of the following:

Process validation and verification activities. (IQ, OQ, PQ, PPQ)

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 highly desired

Hands-on experience in manufacturing, quality & process disciplines.

Minimal travel required (<10%).

Tegra Medical is an Equal Opportunity Employer


Keywords: Tegra Medical, Fall River , Quality Engineer, Other , Dartmouth, Massachusetts

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