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Quality Assurance Specialist
2 months ago
Responsibilities:
\u2022 Analyze and report data to monitor quality performance and ensure customer requirements are met.
\u2022 Conduct training of personnel on internal procedures.
\u2022 Prepare Control Plans and support updates of Procedures or Checklists as applicable.
\u2022 Coordinate Product FAI's and verification of supplier parts.
\u2022 Participate or lead external audits and witness testing at suppliers' facilities, if appropriate.
\u2022 Investigate product / process quality issues and initiate Customer Initial Complaint Notifications (CICN) as appropriate.
\u2022 Act as a facilitator and team member for corrective action or 8D activities.
\u2022 Conduct internal product, process and procedure compliance audits, as appropriate.
\u2022 Maintain good relationships with all functional groups and locations within the Company by participating in functional and multi-functional teams.
\u2022 Maintain good relationships and liaison with external customers and suppliers on Quality related matters.
\u2022 Perform trend analysis on Quality data and identify required corrective actions.
\u2022 Support program launch and FAT activities.
\u2022 Support the Implementation as required of error proofing initiatives based on trend analysis performed on long term programs.
\u2022 Perform other duties as related to those outlined above, or which may be completed based on individual skill or experience.
Requirements:
\u2022 Graduate Engineer or Technologist or equivalent work experience (4 years min.)
\u2022 ASQ CQE certification preferred
\u2022 Five (5) years' experience in a manufacturing environment
\u2022 Demonstrated ability to work independently and to manage multiple projects from various diverse organizations
\u2022 Lean and/or Six Sigma Experience is an asset
\u2022 Strong problem-solving skills
\u2022 Ability to work as part of a cross-functional team
\u2022 Understanding of change management principles and Change Agent Skills
\u2022 Microsoft Excel, Word, PowerPoint – Intermediate level
\u2022 Working knowledge of ISO requirements – 9001 and 13485
\u2022 Current trained Internal ISO Auditor is considered an asset
\u2022 Highly developed attention to detail
\u2022 Working knowledge of Automation and / or Medical Device industry quality requirements
\u2022 Excellent verbal and written communication skills
\u2022 Excellent reading comprehension
\u2022 Proficient at Blueprint reading
\u2022 Training in GDP and GMP
\u2022 Knowledge of measurement techniques. Able to interpret CMM reports
\u2022 Capable of performing basic measurements using hand tools is required, CMM programming capability is an asset"}
