Global Medical Device jobs in Guelph, ON

ABOUT SPA DENT

Founded in 2009, Spa Dent is a certified woman-owned manufacturer of gels, liquids, pastes,

lotions, balms and medical devices. We specialize in high efficacy, natural Oral Care and Self Tanning products. While oral care and tanning are our core competencies we also offer additional Personal Care and Pet products including: Shampoos, Soaps, Lotions and Sanitizers.

Key to our success is our innovation, our highly rated GMP certified facility and our commitment to customer service and timelines.

We own innovative and natural brands distributed through professional dental, salon and retail channels. We also private label for major Canadian and US drug and grocery chains offering national brand better/equivalents with organic certification and national brand equivalents with 3rd party lab supported “compare to” claims.

Our manufacturing facility is located in Cambridge, ON Canada. With in-house R & D, regulatory and EDI fulfillment. Spa Dent has an agile and responsive team that can easily adapt to meet our customers’ current and future needs!

DESCRIPTION

Responsible for ensuring quality and compliance of products at all stages, from raw material to packaged finished products. You will be responsible for leading the continuous improvement of Quality systems, handling high complexity of quality issues for new product development existing product development, internal/external audits as well as providing quality oversight to all business units of Spa Dent.

RESPONSIBILITIES

• Review and conduct Gap analysis for current QMS update QMS system and implement and train staff on QMS.
• Conduct QMS orientation training for new employees and update training for existing employees as required.
• Facilitate and implement changes and improvements to the quality system to ensure the effective and efficient operation of the quality system.
• Design and implement a structured QA testing and validation program.
• Follow-up with vendors when they fail to provide documentation and meet specifications or when deviations to policy / regulation are identified.
• Validating information provided by vendors against Spa Dent & regulatory requirements.
• Validate that specifications are compliant with current regulatory requirements.
• Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality.
• Review marketing documentation to ensure regulatory and internal quality system compliance.
• Review and approve labels to ensure regulatory and internal quality system compliance.
• Document internal audits and other quality assurance activities.
• Investigate customer complaints and non-conformance issues.
• Investigate undesirable trends affecting the quality of products in distribution, performing root cause analysis, and developing and implementing corrective and preventive actions.
• Serve as the primary contact for any external or internal audit, with responsibility to implement any resulting corrective actions.
• Support standards and audits required for facility certification by Health Canada & CFIA, ISO 13485, ISO 22716 and any other quality requirements.
• Monitor risk management activities.
• Lead recalls, mock recalls, hold notifications, stop-shipments, etc., in consultation with management.
• Assure ongoing compliance with quality and industry regulatory requirements.
• Develop and provide training and guidance based on Local and Global QMS and Health Canada and FDA requirements to ensure compliance with GMP Regulatory Requirements, Standard Operating Procedures (SOPs), Departmental Operating Instructions and Protocols.
• Monitor the performance and competencies of Spa Dent staff - along with leadership, coaching and development as needed.
• Manage Quality Assurance Department staff
• Responsible for formal release of all NHPs, Cosmetics and Medical devices.
• Review and Approve batch records, documentation and labels.
• Complete quality and regulatory projects as assigned by CEO.
• Other duties/projects as assigned by CEO.

EDUCATION AND EXPERIENCE

• Bachelor’s degree in Chemistry, Food science or Pharma.
• Masters or Diploma in Quality Assurance or Regulatory preferred.
• Certifications are an advantage including Quality/Lead Auditor, GMP, NHP, ISO Standards (13845, 22716).
• 5+ years of work experience in a quality control/assurance and regulatory role in manufacturing and/or distribution of cosmetics, natural health products or pharmaceutical products.
• Expertise in the development, implementation, and on-going maintenance of ISO 13485:2016 quality management system processes and procedures, ISO 22716 and Natural Health Product GMPs.
• Experience with quality systems, including but not limited to validation, non- conformance, CAPA systems and investigations, laboratory controls, production and process controls, is required.
• In-depth understanding and working knowledge of Health Canada, EU regulations and FDA requirements for Natural Health Products (NHPs), Cosmetics and Medical Devices and regulations for importing and distribution.
• Hands on experience with ISO 13485, ISO 22716-certification process, NHP Licensing process and conducting internal audits based on ISO 13485, ISO 22716, NHP-GMP and Health Canada requirements for Medical devices, Cosmetics and Natural Health Products.
• Proven coaching, training & leadership skills and proven ability to develop leaders & employees.
• Strong communication skills along with the ability to interact effectively with frontline employees, peers, and executives.

Pay Rate: $35.00 - $50.00 based on experience.

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

Pay: $35.00-$50.00 per hour

Expected hours: 40.0 – 44.0 per week

Benefits:

• Dental care
• Extended health care
• Vision care

Work Location: In person