CX - 1289 Quality Engineer II

Coghlin Companies Inc; West Boylston (MA); Vor Ort; USD 85.000 - 110.000; Vollzeit

Zusammenfassung

Cogmedix in West Boylston, MA seeks an experienced quality leader to drive compliance across electro-mechanical manufacturing. You will mentor teams, lead process improvements, and ensure all outgoing products meet regulatory standards.

The role emphasizes root cause analysis, CAPA implementation, and cross-functional collaboration with engineering, supply chain and operations. A Bachelor’s in science or engineering and 7+ years in manufacturing are preferred.

Qualifikationen

• Bachelor’s degree, preferably in a science or engineering discipline; significant and applicable professional experience may be considered in lieu of certain educational requirements.
• Minimum of 7 years professional experience in electro-mechanical manufacturing field preferred.
• Experience in ISO 9001 requirements is preferred.
• Strong electro-mechanical orientation.
• Knowledge of IPC 610 and 620 standards beneficial.
• Six Sigma trained/certified or knowledge of statistical analysis methods and techniques.

Aufgaben

• Lead by example and promote strict compliance at Columbia Tech.
• Train personnel on workmanship and quality standards.
• Provide guidance and oversight to multiple teams, including mentorship.
• Develop and implement improvements and processes, becoming a quality expert.
• Ensure outgoing product is manufactured in a compliant manner.
• Support process qualification/validation and new product introduction processes.
• Develop and execute Quality Plans for customer accounts.
• Review device history records for quality approval.
• Drive root cause analysis and implement corrective actions.
• Support supplier quality with non-conforming material issues resolution.
• Collaborate with cross-functional teams to determine root causes of customer issues.
• Assist in regulatory audit for customer accounts.
• Maintain strong data collection, metrics and presentations for customers.

Kenntnisse

Positive attitude

Customer service oriented

Teamwork & communication

Six Sigma knowledge

Ausbildung

Bachelor’s degree in science or engineering

Tools

MS Word

MS Excel

MS Visio

Jobbeschreibung

Cogmedix
127 Hartwell Street
West Boylston, MA 01583, USA

Description

Responsibilities:

• Lead by example and promote the criticality of strict compliance adherence at Columbia Tech.
• Lead in the training of personnel on workmanship and quality standards, where applicable.
• Responsible for providing guidance and oversight to multiple teams, including mentorship.
• Develop and implement various forms of improvements and processes, becoming an expert in the field.
• As part of the Columbia Tech team, assure all outgoing product is manufactured in a compliant manner.
• Support process qualification/validation and new product introduction processes, where applicable.
• Development and execution of Quality Plans for customer accounts.
• Review device history records for quality approval, where applicable.
• Drive improvement of Columbia Tech Quality through analyzing non-conformances (NC’s) and performing root cause analysis of discrepancies. Propose, review and implement approved corrective and preventive actions.
• Expert in the generation of corrective actions and determining root cause of issues and Complaints. Using various techniques including but not limited to Reenactment, PFMEA, Control Plans, Five Whys, Ishikawa (fishbone) Diagrams, Pareto Analysis, etc.
• Support Supplier Quality Engineering with non-conforming material issues resolution with suppliers, where applicable.
• Collaborate with cross-functional team to help determine root cause of customer issues.
• Support the Quality Control inspection process, where applicable. Assurance Forms (QAF’s), when required. Provide Training, as needed.
• Support the development of quality Receiving Incoming Inspection (RII) plans, as needed.
• Assist in regulatory audit for customer accounts.
• Continually build strong rapport, collaboration and interactions with customers through data collection, metrics generation and presentations.
• Promptly respond to manufacturing floor quality issues, taking appropriate action within the Columbia Tech Quality System.
• Work with Manufacturing Engineers, assembly, production and test to identify trends and propose and implement corrective actions.
• Collaborate with Engineering to develop optimal work order routings, where applicable.
• Collaborate with Supply Chain, PM’s and Operations on managing the Material Review Board (MRB) process.
• Support improvement projects, where applicable.

Qualifications:

• Positive attitude, self-motivator, and tenacious follow up required.
• Superior customer service attitude.
• Excellent teamwork, communication, and interpersonal skills.
• Bachelor’s degree, preferably in a science or engineering discipline. Significant and applicable professional experience may be considered in lieu of certain educational requirements.
• Minimum of 7 years professional experience in electro-mechanical manufacturing field preferred.
• Experience in ISO 9001 requirements is preferred.
• Strong electro-mechanical orientation.
• Knowledge of IPC 610 and 620 standards beneficial.
• Advanced Level Skills in MS Word and Excel such as keyboard short cuts, creating macros and forms, table techniques, working with images, text and pivot tables.
• Advanced Level Skills in MS Visio such as creating Visio diagrams, creating custom styles and templates, cross functional flow charts, linking drawings to other MS applications, working with data, custom reports, and exporting is valuable.
• Six Sigma trained/certified or knowledge of statistical analysis methods and techniques.
• Member of a Quality organization (i.e. ASQ).
• Certified Quality Engineer (CQE) preferred.

Salary Range:

$85,000- $110,000 per year (Salary commensurate with experience)

Cogmedix is an Equal Opportunity Employer. Cogmedix does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Qualifications

Behaviors

Preferred

Functional Expert

: Considered a thought leader on a subject

Detail Oriented

: Capable of carrying out a given task with all details necessary to get the task done well

Motivations

Preferred

Goal Completion

: Inspired to perform well by the completion of tasks

Self-Starter

: Inspired to perform without outside help

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.