Current Postings
 
Quality Assurance Specialist     Levelton Consultants Ltd.          Job posted on July 15, 2010
Quality/Regulatory Manager      Starfish Medical                       Job posted on June 17, 2010


Quality Assurance Specialist
 

Levelton Consultants Ltd. is an established and highly respected medium-sized firm of about 180 multi-disciplined consulting engineers, scientists, and technologists and a leading provider of engineering offered nationally and internationally to resource industries, utilities, government, and design consultants (for further information on Levelton Consultants Ltd., please visit our website at  www.levelton.com).

 

To continue planned growth and to meet an extremely busy workload, there is an immediate need for an energetic and business-minded individual in our Construction Materials Division located in our Richmond Office.

Core Job Responsibilities


The Quality Assurance Specialist will be a key member of the Quality Assurance Group and will be responsible for providing Quality Management, Quality Assurance, and Quality Control services for construction materials engineering and civil infrastructure projects.  The core job responsibilities will involve:

  • Reviewing specifications for constructability, completeness, and Quality Assurance/Quality Control issues;

  • Developing specifications for Quality programs;

  • Managing and maintaining Quality Management/Quality Assurance programs for Owners or Quality Control plans for Contractors;

  • Qualifying materials and submittals;

  • Conducting field, plant and shop surveillances;

  • Reviewing Quality programs and performing various types of audits (service, process, or system);

  • Supporting managers and personnel on all quality issues related to their projects; and

  • Contributing to specific quality initiatives as defined by management.

 Qualifications

 The ideal candidate will have the following knowledge, skills and abilities:

  • Graduation from a recognized university or technological institute, or equivalent training, in the field of civil engineering;

  • Minimum five years related experience in the construction industry with a background in Quality Management, Quality Assurance, and/or Quality Control;

  • Previous experience or training in ISO 9000 Quality Management Systems;

  • Membership or eligibility for registration with APEGBC, ASTTBC, ASQ, IRCA, or similar professional organization;

  • Ability to read and understand technical contracts, drawings, and specifications;

  • Excellent verbal and written communication skills;

  • Good decision making skills;

  • Superior interpersonal skills and the ability to resolve conflicts; and

  • Excellent organizational skills and the ability to work independently with a minimum of supervision and direction.

 

Levelton offers a competitive compensation package, challenging projects, and an opportunity to develop a solid and rewarding career If you meet the qualifications and desire to be part of the growth of a strong team providing superior and innovative customer service, please forward your resume with the position title in the subject line to hr@levelton.com or fax 604-278-1042, attention Manager, Human Resources.

 

We thank all applicants for their interest; however, only those selected for an interview will be contacted.

No telephone enquiries, please.



Quality/Regulatory Manager
 

Founded in 1994, StarFish Medical is a leader in developing and manufacturing custom medical devices.  StarFish offers contract design services in the high technology field of medical products, including Manufacturing/Production capability.  The company is certified to ISO 13485,the medical equivalent of ISO 9001. 

Along with their Manufacturing team, StarFish Medical has a select team of experts in Engineering Physics, Electronics, Software, Embedded Design, Mechanical Engineering, Industrial Design, Regulatory Affairs and Quality Assurance.

  

Job Description:

 

Reporting directly to the President and CEO of Starfish Medical, the Quality/Regulatory Manager is a member of the senior management team and is responsible for ensuring all members of the organization understand and adhere to all aspects of the Starfish Medical quality management system (QMS). The Quality/Regulatory Manager is expected to interact and communicate effectively with all departments of Starfish Medical, ViVitro Labs Inc., the customer base, regulatory bodies and any related contracting services.

 

The role of the Quality/Regulatory Manager is to implement a quality management system which ensures all of the company's products and services meet or exceed the customers' expectations for quality and that Starfish Medical maintains compliance with applicable regulatory requirements.

  

Responsibilities: 

  • Ensure StarFish is fully compliant with ISO 13485 and FDA QSR.

  • Maintain the standard operating procedures owned by the QA/RA department and working with the other department managers to maintain the other standard operating procedures.

  • Monitor quality performance through the use of internal audits, customer surveys and internal product testing

  • Manage the corporate Corrective and Preventive Actions (CAPA) system.

  • Document quarterly Management Reviews.

  • Ensure metrics are meaningful and provide a solid, proactive foundation for business decision making and execution.

  • Training of staff on the QMS and all quality and regulatory related issues.

  • Preparation of regulatory requirements reports for new products.

  • Work with Product Development team to implement and optimize QC tests for final release of all manufactured product and monitor effectiveness.

  • Manage and drive solutions to Non-Conformance Reports (NCRs), customer complaints and vendor corrective actions.

  • Support for QA/Regulatory issues in our sister company, ViVitro Labs.

Requirements:

  • Post Secondary Degree, ideally in Engineering, Sciences or Business.

  • Min. 10 years experience in development and implementation of quality systems in a manufacturing and engineering environment.

  • The ideal candidate would have medical or other regulated industry experience.

  • Understands engineering design/development requirements with an insight to the effective balance between quality assurance and design innovation.

  • Excellent analytical skills and the ability to extract meaningful conclusions and direction from complex data sets.

  • Critical thinking skills are mandatory.

  • Predilection for action and accountability.

  • Strong decision making ability.

  • Excellent communication and negotiation skills.

  • Problem solving and strategic planning.

Salary will commensurate with skills and experience along with a profit sharing package.  Please provide salary expectation when applying.  We thank all those who apply to Starfish Engineering, but only those candidates selected for an interview will be contacted, no phone calls please.

 

Please e-mail your application to careers@starfishmedical.com.  Please ensure the position title is in the subject line.  When sending your attachment, please ensure it is in Microsoft Word (.doc), Adobe Acrobat (.pdf) or text (.txt) format.  You can also fax your resume to (250) 483-1975.


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