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Project Quality Engineer - Moog Industrial:

 

FOR DETAILS AND TO APPLY

 

 

Quality Manager - Nissha Medical:

 

ESSENTIAL FUNCTIONS AND BASIC DUTIES (other duties may be assigned):

Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, policies and Standard Operating Procedures to ensure that customer requirements and industry standards are met.

Demonstrates knowedge and acts in accordance with NMT's Employee Guidelines and applicable quality standards as outlined in NMT's Quality Manual.

Responsible for implementation and management of the Qualiy Management System.

Responsible for the establishment and tracking of Quality KPI's.

Develop short and long-range Quality Department plans and budgets.

Develop and implement standards, methods, and procedures for process validations, equipment calibration and contamination control.

Implement and ensure execution of all inspection activities.

Assure that all work performed conforms to 21 CFR 820, EU MDR 2017/245, Health Canada SOR/98-282 and ISO 13485 standards and is conducted in accordance with cGMP regulations on the production floor.

Write, revise and review Standard Operating Procedues (SOPs), validation protocols and test plans and protocols that are pertinent to company product quality.

Oversee the resolution of customer's technical issues and complaints.

Schedule and conduct corporate Management Reviews.

Identify and implement process improvements.

Address and implement corrective and preventive actions.

Manage the scheduling and execution of internal and external audits.

Act as primary company interface with the FDA and ISO 13485 Registrar.

Responsible for the selection, supervision, and performance management of department employees.

Participate in staff management training and effectivelymanage employees in compliance with federal and state employment laws and regulations.

Interview, hire, and train new department employees.

Conduct timely performance reviews, establish clear goals, and support learning opportunities for job skills and career growth.

Abides by all safety and security rules set forth by the company and regulatory agencies.

 

 

MINIMUM QUALIFICATIONS:

 

Qualification and Experience:

 

Three years' experience required in an ISO 13485 and FDA regulated medical device environment.

Experience in process improvement methods desired.

Experience reading and understanding regulations, standards, drawings and procedures.

Supervisory exerience strongly preferred.

 

Education:

 

Bachelor's degree in Business, Science, or Engineering required. Master's degree preferred.

CQM Certification desired.

 

Knowledge, Skills and abilities:

 

Knowledge of FDA cGMP and validation requirements and practices required.

Working knowledge of the operation of related instrumentation.

Proficient computer skills with documentation related databases and Microsoft Office (Word and Excel).

 

Physical Requirements:

 

This position requires the physical ability to:

- Frequently remain in as stationary position for long periods of time.

- Regularly use hands and fingers to make small movements and handle small parts/tools.

- Frequently reach with hands and arms.

- Perform repetitive tasks using wrists, hands and fingers.

- Occasionally move between buildings and offices (campus environment)

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Special Work Conditions:

 

This position is exposed to quiet Office noise. May be exposed to inclement weather when moving between buildings on site..

 

 

HOW TO APPLY:

For more information and to apply send email to Jessica Potter, Director, North American Quality and Regulatory, Nissha Medical Technologies: jpotter@nisshamedical.com

 

 

Quality Engineer - Conax Technologies:

 

Position Details:

Conax Technologies… great minds don't necessarily think ALIKE… solutions and innovation happen when we think TOGETHER. Engineering Solutions to your complex challenges for over 60 years! Compression seal fittings, temperature sensors and custom solutions for Aerospace, Oil & Gas, Power Generation, Semiconductor, and other Technology, and Industrial marketplaces.

 

We are growing and looking to add a Quality Engineer to our team.

 

When you join Conax, you will be rewarded with a competitive salary, great benefits, and a culture that values integrity, commitment, innovative thinking, customer service, and teamwork.

 

The work you'll do:

 

Develop and implement quality related procedures and instructions.

Develop, implement and monitor quality standards for new and existing products, collaborating with R&D, Product Engineering and Operations to ensure alignment with customer expectations and manufacturing process capabilities.

Manage the systematic corrective and preventive actions (CAR) process – initiate, review & oversee adequacy of root cause analysis, corrections, corrective actions, preventative actions and effectiveness.

Oversee calibration (electrical and mechanical) program – Metrology.

Participate in compliance audits, customer audits, and vendor audits; conduct internal audits of the Quality Management System.

Complete Quality related customer surveys/inquiries.

Generate or assist in the generation of conformance certifications.

Complete First Article Inspections.

Assist in the vendor qualification and evaluation program; audit and collaborate with critical suppliers to development and maintain raw material specifications, material traceability and ongoing compliance standards.

Participate and/or lead in disposition of non-conforming materials.

Develop, maintain and report internal quality metrics (KPIs) and trend analyses to management such as but not limited to: CAR, Customer Complaints and Non-conforming Material.

Work with cross-functional teams to assist in the development of engineering studies and validation protocols.

Work with manufacturing personnel to ensure on-going compliance with quality system regulations.

Work with cross-functional teams to assist in Risk Management activities and the compilation of Risk Management reports.

  • Work on continuous improvement projects to identify root causes and reduce scrap utilizing Lean Six Sigma methodology.
  •  

    Who you are or want to become:

    A leader who can act as the Quality Director's backup.

    An example to other teammates when it comes to our core values of integrity, commitment, innovative thinking, customer service, and teamwork.

    An internal quality expert.

    Someone who relies on their experience and judgment to plan and accomplish goals.

     

    Job Requirements:

     

    Skills and experience you'll need:

     

    Minimum of 5 years' experience in quality engineering.

    Ability to collaboratively and effectively interact with production and engineering teams to proactively advance QMS.

    Ability to partner with manufacturing engineers and R&D teams to establish quality plans including the identification of measurement tools and gages and creation of operator training programs for new product introductions.

    Working knowledge of risk management processes and hands-on experience in risk management tools (FMEA, Risk Assessment, etc.).

    Working knowledge of ISO/IEC 17025 and Nadcap.

    Working knowledge & Internal Quality System experience for Aviation, Space and Defense Organizations (AS9100).

    Proficient with technology, able to utilize and create documents in the Conax Technologies Wiki and regularly utilize MS Excel, Word as well as other internal software and systems.

    Certified Auditor (preferred)

    CQE, CSSBB and/or CQA (desired)

     

    Education:

     

    Bachelor's degree in a technical/professional discipline

     

    We are an Equal Opportunity Employer who values its people at all levels.

     

    How to apply:

    For more information and to apply send email to Nicolette Weber, Director, Culture and People Development Conax Technologies: nicolette.weber@conaxtechologies.com

     


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