Epocal Career Opportunities

Description:

Under the direction of the Vice President Quality Assurance & Regulatory Affairs provide leadership and oversight to Epocal’s quality management system while ensuring compliance with:
• ISO13485
• FDA Quality System Regulation
• Health Canada Medical Device Regulations and
• Other international requirements as applicable, e.g. IVD Directive for CE Marking.

Key Accountabilities and Major Activities:

• Act as company's quality system Management Representative.
• Maintain and improve quality system documentation, i.e. policies and procedures to ensure ongoing compliance with quality system standards and requirements as well as current company and industry practices.
• Maintain quality systems that assure product conformance and customer satisfaction.
• Manage specific quality systems, i.e. management review process, corrective and preventive action system, non conforming goods system, final product release, etc.
• Develop quality plans and recommendations for improvement.
• Represent QA in the engineering change control process.
• Facilitate and implement changes and improvements to the quality system to ensure the effective and efficient operation of the quality system.
• Develop training materials and conduct quality system training.
• Collect and analyze data from quality processes and generate regular reports.
• Lead, coordinate and conduct quality system audits and management reviews.

Contacts:

• Reports directly to the Vice President, Quality Assurance & Regulatory Affairs.
• Works closely with the Document Controller and other department staff.
• Regular interaction across all departments including but not limited to: (1) Manufacturing, (2) Mechanical Engineering, (3) Biosensors,(4) Systems Engineering,(5) Reader Production.
• Interaction will be with all levels of operations and some key customers/suppliers.

Job Challenges /Complexities:

• Strict attention to detail
• Juggling and prioritizing multiple tasks within a dynamic work environment with tight timelines and limited resources.
• Scaling of the quality system to suit a rapidly growing company.
• Ensuring compliance while meeting business objectives.
• Recruits and Qualifies internal quality auditors

Education:

• University Degree (preferably BSc, Engineering and/or formal training in QA).
• Seven (7) years or more experience within ISO registered manufacturing environment - preferably in medical devices.
• ISO13485 and FDA Quality System Regulation (QSR) experience essential.
• ASQ certified designation: Certified Quality Auditor (CQA), Certified Quality Manager (CQM) or Certified Quality Engineer (CQE) preferred.
• Must be a qualified ISO13485 internal auditor (SCC or RAB accredited Lead Auditor designation preferred).

Attributes / Competencies:

• Openness, Honesty and Integrity
• Independent collaborative self-starter with the ability to make appropriate quality-related decisions in real time.
• Process orientated, Logical, analytical, meticulous, highly organized and able to analyze data & implement solutions.
• Proven ability to work effectively within a team environment while satisfying individual responsibilities and objectives.
• High level computer literacy; including MS Office, SharePoint, Flowcharting software, Acrobat, etc.
• Excellent high level oral & written communications skills enabling incumbent to act as a facilitator and/or educator with strong leadership skills.

Description:

Reporting directly to the President & C.E.O., the new Senior Vice President Manufacturing Operations will be an integral part of Epocal’s leadership team providing direction and leadership to the company’s manufacturing, engineering, supply chain and logistics operations to achieve production targets and related business objectives.

Major Activities:

• Develop and implement successful manufacturing operational & maintenance strategies for Epocal products to meet and exceed company production objectives.
• Analyze current business capability and other dynamics to identify key priorities for response, including leveraging internal/external resources to maximize production and output.
• Developing, directing and implementing strategic manufacturing management plans, policies, procedures and systems in order to best achieve overall manufacturing, quality and delivery targets.
• Provides leadership and advice to team in determining “root cause” of issues and creates solutions to address problems by applying leadership skills to provide effective coordination and direction.
• Develop, direct, and support Manufacturing team by developing highly effective operational systems, tools and training programs to enhance internal capability.
• Capacity planning of operational resources (materials/tools/equipment/people) to fulfill department responsibilities, including negotiating cross-departmental dependencies and resource sharing
• Providing effective operations/maintenance management, ensuring that all reports and related activities are within required guidelines and operational parameters
• Accountable for all aspects of product manufacturing including the development and implementation of short and long term tactical production and maintenance plans.
• Ensuring compliance with all regulatory issues related to operations by coordinating methodologies to provide oversight of operations for compliance with regulatory standards, company standards, timelines, budgets and other obligations
• Manage the interfaces between the Manufacturing teams and the rest of the company within the scope of the position.
• Establishing and monitoring key performance metrics
• Assessing and recommending operational changes where necessary
• Analyzing forecasts vs. actual
• Assessing engineering process and design proficiencies unique to each area/department.
• Optimizing efficiency by championing leading edge manufacturing techniques and all related principles.
• Evaluating performance of direct reports based on operational activities
• Ensuring excellence in product quality, on time delivery, set targets and strategies for realistic new business objectives providing guidance to subordinate teams.
• Guide teams in operational decisions, technical or engineering concepts, new operational potential outputs to meet demands for each

Contacts:

• Reports directly to the President & CEO and is a member of the Senior Management Team.
• Regular interaction with department heads, engineers, technicians, and other professional staff.

Job Challenges/Complexities:

• Dynamic “start-up” environment with extremely short decision-making hierarchy and cross-functional interdependence.

Requirements:

• Minimum of a Bachelor’s degree with a Masters preferred, a PhD a strong asset in Mechanical, Electrical, Industrial Engineering
• 10-15 years of progressively responsible experience in Manufacturing
• Understands the demands of a manufacturing environment and has prior experience working for a company whose products and processes are FDA regulated
• Solid knowledge of leading edge Manufacturing operations
• Minimum of 5 years Senior Manufacturing Management experience principally focused on operations.
• Strength in leading and developing teams with a proven track record of having successfully managed manufacturing and engineering staff in the production of goods, ideally medical device related.
• Must be a big picture thinker and implementer.
• Innovative leader who blends strategy, operations, technology, and analytics to produce outstanding business results.
• Confident and effective communicator with strong interpersonal and team-management skills, driven to achieve goals and exceed expectations.
• Project management orientation
• Self starter and can work independently on projects as required
• Effective, customer focused
• Team player