Quality Manager

Position Purpose

The purpose of this position is to develop, implement and monitor quality strategies. This position ensures compliance with established standards and agency guidelines such as ISO 13485:2016, Health Canada and US FDA by providing direction to QA/QC and Regulatory Affairs team members to maintain and improve quality and regulatory compliance. This position is also responsible for international QA, QC operations including disposition of products, investigation and approval of materials, products and procedures. Act as a backup for the QA/QC inspector or QA/RA Associate to support Canada, Singapore and international business.

Summary of Responsibilities

Develop and implement QA strategies. Act as a Management Representative and implement quality system procedures and initiatives in order to achieve compliance with requirements. Coordinate and lead internal and external audits, maintain quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of the products conform to established standards and agency guidelines. Provide leadership for quality system improvements, and business process improvement initiatives. Responsible for creation, preparation, and achievement of regulatory submissions and approvals to introduce new products in the US, EU, Canada, Australia and other markets.

Key Responsibilities

· Direct Quality Assurance (QA) functions and teams to implement QA policies and procedures

· Lead (prepare, arrange and execute) internal audits for compliance to CGMP, ISO 13485, Health Canada and International Regulations related to medical devices, natural health products and pharmaceutical products

· Lead NCMR, CAPA and improvements in Quality area

· Perform internal and external audits of NeilMed facilities and outside suppliers and vendors as required

· Provide training and guidance to QA team members for routine QA rounds, improvements in GMP, SOPs, forms, validation protocols and reports

· Review and approve procedures, forms, protocols, reports and specifications for US, Canada, Singapore, Europe and other international markets

· Oversee quality and product releases in US, Canada, Singapore and other international markets. Act as an authority to release products in absence of local QA professional at various sites in US, Canada, Singapore and other international markets

· Review and approve product release documents/records (certificate of analysis, certificate of manufacturer, inspection reports, investigation and CAPA reports and other product disposition related records) for US, Canada, Singapore, Europe and other international markets

· Lead or assist Management Review per current Quality Systems requirements

· Support stability studies for products by review and approval of stability protocols and reports

· Support Regulatory submissions and on-going regulatory compliance for product development process if needed

· Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes

· Review and approve submissions and approvals, including design and manufacturing changes and labeling

· Act as Management Representative for the Company if required by the Company

· Oversee Risk Management and provide input in design verification, design validation, shelf life studies

· Provide technical guidance and training/mentoring to other QA employees and cross-functional teams

· Supervise 4-5 direct reports. Participate with peers in the formulation of overall direction, processes, systems and talent development for the Quality department and Company

· Develop and implement departmental and divisional policies and procedures

· Other duties as assigned

KNOWLEDGE/EDUCATION

· Bachelor or Master in Science (Preferred Biology or Chemistry or related fields)

· Certified Quality Auditor by ASQ (Preferred)

· Knowledge of FDA regulations, guidance, and import/exports requirements for Medical Devices, Natural Health Products and Pharmaceuticals

· Knowledge of European Device Directive and of applicable guidance documents (MEDDEV, NBMED, etc.)

· Knowledge of Health Canada regulations (Preferred)

· Knowledge in product labeling and promotional requirements

· Strong understanding of the quality system requirements

· Thorough knowledge of product development process, design control and Quality Systems

· Strong technical knowledge of medical device products

EXPERIENCE

· Minimum 5 years of Quality experience as manager or higher level position

· Minimum 5 years experience with demonstrated success managing and developing team of at least 4 direct reports

· Demonstrated success in Quality management

· Knowledge or experience in Risk management, CAPA management and Quality improvements

· Statistical analysis and problem-solving ability strongly preferred

SKILLS/COMPETENCIES

· Proficient in timely review of technical and clinical data.

· Proficient in FDA and international regulations (EU and Canada)

· Technical knowledge of medical devices

· Good presentation skills

· Computer skills; MS Word, PowerPoint, MS Project, Adobe Acrobat, Excel

· Strong written and oral communications skills

· Detail oriented and Self-motivated.

· Ability and commitment to working both independently and as part of a team

· Excellent negotiation and problem solving skills

· Ability to write clear, concise, and well thought out technical documents

· Able to manage moderately complex problems/projects by exercising independent decision making and analytical thinking skills

· Ability to work under minimal supervision and independently

· Must be able to work in a timeline-driven environment

Job Type: Full-time

Pay: $64,087.57 - $125,271.09 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Education:

• Bachelor's (Required)

Experience:

• Quality management: 5 years (Required)

Work Location: In person

Salary : $64,088 - $125,271