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DNA Genotek: Quality Systems Manager

DNA Genotek

This is a Full-time position in Ottawa, ON posted April 17, 2021.

Overview:Leader with responsibility for oversight of OraSure’s electronic software solutions utilized to manage the quality systems across the enterprise for the infectious disease, Molecular and Services businesses.

Provides oversight of the deployment of these systems to key contract manufacturers and partners as deemed necessary.

Assures that the execution of the procedures that utilize these solutions are consistent and high quality by developing, maintaining and managing the Quality System for compliance to applicable US FDA, ISO EU, Canadian, and other International Ministry of Health requirements applied to currently approved products and products under development.

Serves as shared service quality systems resource for each of the management representatives in the respective businesses.Responsibilities:Provide coaching, direction and advice on practical application of Quality System requirements to QA staff and key partners (ie Operations, Engineering, R& D).Serve as Project leader for new quality system implementations.Serve as primary contact with software vendors in the day to day management and support of the system.

Responsible for assessing, budgeting and managing the costs associated with running these systems.Ensures that the appropriate resources are allocated to support the software systems under their purvue.Liase with IT on infrastructure and IT requirements.The Quality Assurance Manager ensures DNA Genotek products and services meet customer and requirements and are right the first time.

In addition, they are responsible for maintaining the compliance of our the Quality Management System (QMS) to applicable requirements including ISO 13485:2016, ISO 9001:2015, FDA Good Manufacturing Practices (or QSR), and MDSAP while also enabling agility where possible for unregulated products.

The Quality Assurance Manager works closely with cross-functional teams to ensure our suppliers and outsourced manufacturing partners consistently meet specified requirements.Manage internal audit program and work with process owners to improve & ensure compliance of their procedures.

Ensure smooth execution of electronic quality systems (ie Electronic Batch records, Electronic Document Control, NCR / CAPA, Training, Audits, Calibrations).Manage corrective and preventative action (CAPA) process and lead continuous improvement activities.

Serve as Project Leader in the implementation of new electronic quality system solutions.Manage document control functions., maintains implementation of ETQ QMS software platformLead or supports periodic management reviews.Support compliance with ISO 14971 medical device risk managementPartner with cross-functional team to audit suppliers, qualify new suppliers, and monitor performance of current suppliers, including supplier corrective action reports.Work with departments to develop and monitor key performance indicators to assess performance of organization and guide improvement efforts.

Supports management representatives in the compliant execution of their quality systems.

Investigate customer complaints and product returns.Participate in new product introduction, customizations and product change processes to drive quality by design.

Attend design reviews, inspection and test planning, and review product design verification and validation plans and reports.Manage and provide training to employees on aspects of the QMS that are relevant to their role.Provide management leadership to direct reports including objective setting, personal development and mentoring.Maintain performance metrics with key performance indicators and prepare reports as requested.Ability to travel up to 25% of their time.Qualifications:Degree in a business, science or engineering discipline, or an equivalent combination of relevant job experience, training and knowledge.

Master degree preffered.ASQ Certification ed (ie Manager of Quality / Organizational ExcellenceQuality Engineering / Auditor) desired.Minimum 5 years experience in a Quality Management role, preferably in a Medical Device environment (ISO 13485:2016, FDA 21 CFR part 820)Excellent analytical and problem solving skills, including previous experience with Statistical Process Control, Design of Experiments, and root cause analysis.Experience working with at least two of the following electronic systems: CAPA/NCR, Document Control, Training, Audits, Calibrations, Electronic Batch records.Demonstrated success in achieving Quality objectives in a company, applying continuous improvement tools to problems, leading organizational change.Demonstrated resourcefulness and ability to work with a diverse set of tasks and responsibilities.Proven leadership and developmental abilities.Strong time management, organizational and communication (written and oral) skills.Experience conducting supplier audits and managing supplier quality programs.Ability to conduct formal presentations in group settings and convey technical information.Experience working with Enterprise systems such as SAP.At DNA Genotek, we are committed to building and preserving an accessible, welcoming, supportive, fair, and inclusive environment.Accommodations are available to support prospective employees during the recruitment and hiring process.

Should you require any accommodations, please advise us in advance so that we can work with you to find a suitable accommodation.