CX - 1289 Quality Engineer II

Coghlin Companies; West Boylston (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

Cogmedix is seeking a Quality Engineer with a strong electro-mechanical manufacturing background to lead quality initiatives and ensure compliant production.

You will develop quality plans, review device history records, and drive CAPA through root cause analysis. Collaboration across engineering, manufacturing, and supply chain is essential to improve processes and prevent non-conformances.

Qualifications

• Bachelor’s degree in science or engineering or equivalent experience.
• 7+ years in electro-mechanical manufacturing environment.
• Experience with ISO 9001 requirements preferred.
• CQE certification preferred.

Responsibilities

• Lead in promoting strict compliance and quality adherence.
• Develop and implement quality plans for customer accounts.
• Review device history records for quality approval.
• Drive and implement corrective and preventive actions (CAPA).
• Support process qualification/validation and new product introductions.
• Collaborate with cross-functional teams to resolve customer issues and improve quality.

Skills

Six Sigma

Root cause analysis

ISO 9001

IPC 610/620

CQE

Quality systems

MRB process

Quality planning

MS Excel (macros)

MS Visio

MS Word

Education

Bachelor’s degree in science or engineering

Tools

Visio

Excel

Word

Job description

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.