Principal Engineer - Software Validation

  • Category
    Industrial & manufacturing - Quality Control
  • Job type
    Temporary/Contract
  • Location
    Kanata, Ontario

Adecco is currently hiring a Principle Engineer – Software Validation to work with a large Medical Manufacturer in Ottawa. To qualify for this role, you must have an advanced technical understanding of Quality Systems/Policies/Procedures and medical devices or pharmaceutical products, Bachelor's degree or equivalent experience required and a minimum of 6 – 10 years of medical device or pharmaceutical industry experience.

The position includes management of personnel and activities within the quality operations and manufacturing environment. Completes professional level engineering and management assignments related to software validation, data integrity and application of 21CFR part 11 requirements. Leads and participates in projects involving design, fabrication, validation, calibration and test of complex instrument subassemblies, systems or processes. Compensation for this role will be determined by both experience and education level. This contract is for 1 year with the possibility of extension.

Requirements:

  • Advanced technical understanding of Quality Systems/Policies/Procedures and medical devices or pharmaceutical products.
  • Advanced understanding of data integrity requirements for medical devices, including application of 21CFR part 11 requirements.
  • Previous experience interacting with regulatory bodies.
  • Previous experience with operations related quality system requirements.
  • Ability to evaluate complex processes.
  • Demonstrated good judgment and sound decisions.
  • Bachelor's degree or equivalent experience required.
  • Typically requires a minimum of 6 – 10 years of medical device or pharmaceutical industry experience.

Responsibilities:

  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
  • Implements and maintains effective quality system by supporting compliance activities.
  • Manages activities, tasks and priorities of Quality Engineering and Manufacturing staff, including production line support, change control data reviews and investigation and resolution of quality issues.
  • Manages internal metric reports to meet division requirements.
  • Identify and implement process improvements while maintaining compliance to quality regulations.
  • Responsible for non-product software validation requirements, maintenance of the data integrity, implementation and maintenance of system requirements for 21CFR part 11 Electronic Records; Electronic Signatures
  • Ensure EHS goals are established and achieved.  Promote adherence to EHS policies, procedures, rules and regulations.
  • Other miscellaneous duties as may be required.
  • Ability to establish strategic direction and lead change.
  • Demonstrates the appropriate level of leadership experience to lead cross functional teams.
  • Advanced written and verbal communication skills.
  • Ability to confront and resolve conflict and lead efforts to resolve critical situations.
  • Interacts frequently with division management with executive responsibility and requires high levels of competence, confidence and credibility.
  • Strong customer interface skills.

If you are interested in this position, please click the APPLY NOW button below.

B1956

  • Apply with Adecco

Reference number CA_EN_1_021956_1189163

Accommodation will be provided in all parts of the hiring process as required under Adecco’s Employment Accommodation policy. Applicants will need to make their needs known in advance to their Adecco representative.

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