Quality Specialist

**Position Summary**

The primary responsibility of the CA Quality Specialist is to ensure the Quality System’s continuing excellence and compliance to Health Canada’s requirements in Canada, (Milton). The incumbent will ensure ongoing compliance to all applicable Health Canada DIN/NHP and Device regulations, ensure all compliance plan deliverables are achieved, maintain all operations in full inspection-ready fashion, foster a mindset of continuous quality improvement, and be a leading voice in sustaining a culture of quality & excellence.

**Universal Accountabilities**
- Ensure compliance to all Health Canada DIN/NHP and Medical Device GMP requirements.
- Ensure the quality systems are implemented and followed in Milton (e.g. temperature monitoring, calibration program, document control, product testing, specifications, control procedures, etc.).
- Collection and maintenance of retention samples.
- Inspection and sampling of Finished Goods and/or Raw Materials.
- Review. “Release packages”
- Processing of Consumer Complaint samples.
- Produce corrective action and related quality metric reporting, ensuring quality investigations are closed in a timely manner.
- Participate in internal quality system and GMP inspections, prepare report of findings and corrective action report as required to ensure compliance.
- Collaborate with multidisciplinary teams as needed.
- Act as Canadian Release agent in the absence of EPC QA Manager for Canada

**Specific Accountabilities**
- Maintain knowledge of current Health Canada GMP regulations (i.e GUI-0001, 0002, 0069 etc.)
- Update SOPs as needed
- Liaison among Edgewell sites globally.
- Keep evidence and documentations as required by Regulations and internal procedures

**Required Skills and Experience**
- Bachelor of Sciences degree required.
- Minimum of 2-3 years of experience in Quality System in Canada with proven successful track record in a Drug/ Cosmetic/ NHP product company
- Robust Knowledge of (but not limited to) GUI-0001, GUI-0002, GUI-0005, GUI-0069, GUI-0080, GUI-0102
- Knowledge of (but not limited to) SOR/ 98-282, ISO 13485 and ISO 22716
- Knowledge of safe work practices and Ontario Health and Safety Act.
- Proficiency with various computer software (i.e. SAP, Trackwise, Microsoft Office) programs and use of audiovisual tools.

**Preferred Skills and Experience**
- Results oriented analytical thinker with strong problem-solving abilities.
- Collaborative in approach with the ability to influence the decision-making process.
- Excellent interpersonal and communication skills at all levels both within and outside the organization.
- Strong initiative and organizational and project management skills.
- Ability to successfully work within and promote a team environment.

**Working Relationships**
- Internal contacts: Cross-functional team (Purchasing, Operations, Quality, R&D, Engineering, Human Resources, technical support groups) as well as other value streams.
- External contacts: Consultants, contract laboratories, research organizations - technical partnerships such as trade organizations.

Work Environment
- Work schedules that vary from typical business hours.
- Exposure to health risks or conditions that may require the use of Personal Protective Equipment.
- Must be able to travel to off-site locations for meetings; occasional overnight travel required.
- Occasional work to match production hours, might look like 5-10 hours in the evening or weekend.

Environmental, Health and Safety Responsibilities
- Conform to safety regulations and procedures to maintain a safe working environment.
- Performing every job safely, for the benefit of self, co-workers, contractors, and for the protection of facilities. This includes the use of required personal protective equipment and use of safely equipment/devices, guarding, as well as safe work practices.
- Immediately reporting every job-related injury or illness, regardless of severity, to a team leader/supervisor
- Assist in investigating incidents.
- Taking necessary actions to correct or stop unsafe conditions or practices.
- Actively participation in safety meeting and training.
- Review SDS instructions before working with any chemicals or hazardous materials.

Quality Responsibilities
- Colleagues are responsible for their own quality and that of colleagues within their span of control.
- Colleagues are responsible to follow all established Quality procedures and instructions.
- Colleagues are responsible for notifying leadership for corrective action if defects are found and/or parts/processes do not conform to specifications.
- Colleagues are responsible for adhering to applicable Health Canada’s Good Manufacturing Practices work rules as they relate to job-specific duties.

Supplemental Information
- This description is based on management’s assessment of the requirements and functions of the job as of the date this description was prepared. It is a general guideline for managers and