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2 days ago
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Quality Engineer


Salary band: $10k - $15k
Location: North America, United States, Connecticut
Job type: Permanent
Contact: On-Board Services
Category: Quality Engineer
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Job Description

This is a 1 YEAR Assignment in Canaan, CT.

Pay Rate: $35.00 Hourly

Hours: Monday - Friday / 8:00 am - 5:00 pm

**Candidates must complete background and drug screenings prior to start.

Acts as the main point of contact for customer complaints. Resolves moderate to complex customer complaints and works with the Associate Quality Manager (Supervisor) on critical and sensitive issues/customer complaints. Review, evaluate, investigate, analyze and resolve complaints and problems concerning Customers, through close coordination with Operations, Quality, Complaint Group, Marketing & Sales and, by obtaining understanding of customer product expectations and functional needs to represent the customer in-plant decisions. Manages the complaint process at the plant level from start to end.

ESSENTIAL FUNCTIONS

  • Develops solutions to routine problems of limited scope.
  • Follows company procedures for areas of assigned responsibility.
  • Limited knowledge of applicable regulatory, Corporate and/or Unit requirements
  • Effective communicator; ensuring all complaints are acknowledged, investigated and completed in a timely manner.
  • Conducts evaluation of customer complaints; including documentation review, sample testing, and technical evaluation of product defects.
  • Manages the resolution of customer complaints, within given timeframes; identifying the problem, defining containment actions, investigating root cause, establishing corrective and preventive plans in order to eliminate or minimize the failures identified.
  • Works closely with Operations and Quality to identify potential root causes and develop and implement appropriate corrective and preventive actions.
  • Leads problem solving efforts to identify and resolve recurring and new quality issues to ensure production of safe and effective medical devices, which will result in product/process improvements, long-term solutions.
  • Tracks effectiveness of corrective action plans and compliance improvement initiatives.
  • Generates Situation Analysis Reports as needed, directed by the Associate Quality Manager (Supervisor), Quality Manager and other Directors in the Organization.
  • Analyzes data and identifies trends in order to develop innovative solutions; using statistical techniques to identify significant changes and proactively initiates plans/projects to mitigate the risk. Generates weekly, monthly and quarterly reports and others as needed.
  • Provides feedback pertaining to the groups involved in the complaint process.
  • Maintains complaint files according to established polices/procedures.
  • Supports company goals and objectives, polices, and procedures to maintain compliance with ISO 13485, FDA QSR and CE mark compliance.
  • Maintain a professional working relationship with internal and external customer and support staff.
  • Perform other duties as assigned.

JOB QUALIFICATIONS

The Quality Engineer will be responsible for working closely with other functions within the organization (Manufacturing, R&D, Quality, Engineering, Procurement, Marketing) and ensuring the quality of the product and processes for the assigned product line(s) are in compliance with standard Quality practices. The QE will develop, modify, apply and maintain quality standards and protocols and may also be responsible for developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements. Responsible for developing, documenting and/or maintaining design history files.

  • BS degree in Life Sciences, Engineering (Biology, Chemistry, Microbiology, Electrical, Mechanical, Software/Computer Science).
  • 5-6 years of experience in Pharmaceutical/Biotechnology Industry required.
  • Professional certification is preferred (i.e. CQA-Certified Quality Auditor, CQE-Certified Quality Engineer, SQE-Software Quality Engineer, CQM-Certified Quality Manager, etc.).
  • SAP experience preferred.
Company Description
Company Vision
In 2001, the ownership and management of On-Board set forth a corporate vision to become the leading provider of professional services in North America. In pursuit of this vision, On-Board will embrace the core values of superior quality and customer service, strive for continuous improvement in all aspects of our service offerings, assemble, develop and retain the best talent in the marketplace.

Our Mission
On-Boards corporate Mission is to provide Flexible Service by applying the talents of our people, work processes and technology to meet our clients expectations in a safe, responsible and dependable manner consistent with our people and quality principles.
Job Description

This is a 1 YEAR Assignment in Canaan, CT.

Pay Rate: $35.00 Hourly

Hours: Monday - Friday / 8:00 am - 5:00 pm

**Candidates must complete background and drug screenings prior to start.

Acts as the main point of contact for customer complaints. Resolves moderate to complex customer complaints and works with the Associate Quality Manager (Supervisor) on critical and sensitive issues/customer complaints. Review, evaluate, investigate, analyze and resolve complaints and problems concerning Customers, through close coordination with Operations, Quality, Complaint Group, Marketing & Sales and, by obtaining understanding of customer product expectations and functional needs to represent the customer in-plant decisions. Manages the complaint process at the plant level from start to end.

ESSENTIAL FUNCTIONS

  • Develops solutions to routine problems of limited scope.
  • Follows company procedures for areas of assigned responsibility.
  • Limited knowledge of applicable regulatory, Corporate and/or Unit requirements
  • Effective communicator; ensuring all complaints are acknowledged, investigated and completed in a timely manner.
  • Conducts evaluation of customer complaints; including documentation review, sample testing, and technical evaluation of product defects.
  • Manages the resolution of customer complaints, within given timeframes; identifying the problem, defining containment actions, investigating root cause, establishing corrective and preventive plans in order to eliminate or minimize the failures identified.
  • Works closely with Operations and Quality to identify potential root causes and develop and implement appropriate corrective and preventive actions.
  • Leads problem solving efforts to identify and resolve recurring and new quality issues to ensure production of safe and effective medical devices, which will result in product/process improvements, long-term solutions.
  • Tracks effectiveness of corrective action plans and compliance improvement initiatives.
  • Generates Situation Analysis Reports as needed, directed by the Associate Quality Manager (Supervisor), Quality Manager and other Directors in the Organization.
  • Analyzes data and identifies trends in order to develop innovative solutions; using statistical techniques to identify significant changes and proactively initiates plans/projects to mitigate the risk. Generates weekly, monthly and quarterly reports and others as needed.
  • Provides feedback pertaining to the groups involved in the complaint process.
  • Maintains complaint files according to established polices/procedures.
  • Supports company goals and objectives, polices, and procedures to maintain compliance with ISO 13485, FDA QSR and CE mark compliance.
  • Maintain a professional working relationship with internal and external customer and support staff.
  • Perform other duties as assigned.

JOB QUALIFICATIONS

The Quality Engineer will be responsible for working closely with other functions within the organization (Manufacturing, R&D, Quality, Engineering, Procurement, Marketing) and ensuring the quality of the product and processes for the assigned product line(s) are in compliance with standard Quality practices. The QE will develop, modify, apply and maintain quality standards and protocols and may also be responsible for developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements. Responsible for developing, documenting and/or maintaining design history files.

  • BS degree in Life Sciences, Engineering (Biology, Chemistry, Microbiology, Electrical, Mechanical, Software/Computer Science).
  • 5-6 years of experience in Pharmaceutical/Biotechnology Industry required.
  • Professional certification is preferred (i.e. CQA-Certified Quality Auditor, CQE-Certified Quality Engineer, SQE-Software Quality Engineer, CQM-Certified Quality Manager, etc.).
  • SAP experience preferred.
Company Description
Company Vision
In 2001, the ownership and management of On-Board set forth a corporate vision to become the leading provider of professional services in North America. In pursuit of this vision, On-Board will embrace the core values of superior quality and customer service, strive for continuous improvement in all aspects of our service offerings, assemble, develop and retain the best talent in the marketplace.

Our Mission
On-Boards corporate Mission is to provide Flexible Service by applying the talents of our people, work processes and technology to meet our clients expectations in a safe, responsible and dependable manner consistent with our people and quality principles.

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