Job Description:

Description

Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!  

POSITION PURPOSE 

The Senior Advanced Quality Engineer will contribute to product development Core Teams, and be the process owner of both the Process Validation and Risk Management processes for the PDI business.  This position will have opportunities to influence new product designs, identify and mitigate risks, and ensure safe, effective and efficient product transfers into production through implementation of sound process validation techniques. 

Process validation ownership encompasses all aspects of validation occurring within in-house manufacturing, contract manufacturing and computer systems. Quality compliance oversight includes Installation, Operational and Performance Qualifications for equipment, facilities, utilities, as well as cleaning and manufacturing processes in accordance with predefined test protocols. A special emphasis exists on computer system validation, and data integrity in accordance with Part 11 requirements. Development of global procedures and providing instructor led training as required.

Risk Management process ownership includes ensuring compliance with evolving external regulations, (ISO 14971, etc.) enhancing the internal risk management process, and collaborating with R&D, and Operations in identifying and mitigating risks on new product introductions. Development of global procedures and providing instructor led training as required.

Provide leadership, direction and mentoring to ensure that the organization is successful in meeting the quality and manufacturing objectives and support of site specific goals.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

• Process ownership of the Risk Management and Process Validation Systems ensuring they comply with all regulatory requirements and applicable standards including FDA, EPA, ISO and Health Canada.


• Establishing the policies/standards of the Risk Management processes, including risk analyses, risk evaluation, and control in both pre-market and post-market risk management activities to ensure a robust, closed-loop process in order to provide product safety, patient/user safety and compliance in this critical area.


• Leading the organization through change management to a centralized risk management way of working, with improvements in efficiency and optimization, while also ensuring compliance to current and future regulations.


• Regular interactions with Core Teams and their respective senior management across all Business Groups within PDI to ensure integration and implementation of solutions.


• Serves as a subject matter expert and resource within risk management discipline; technical expert on functional or cross-functional teams and projects.


• Sharing Expert knowledge of Risk Management principles and practices including Safety Risk Management (ISO 14971), FMEA’s, and post-market activities throughout the organization.


• Provide strategic leadership, development and implementation of the assigned cGMP QA Systems for drug/device products.


• Oversee and manage all aspects of the assigned quality functions for Validation and Risk Management.


• Quality oversight and approval of internal and external method qualification, method transfer and method validation project plans, protocols and reports.


• Report validation/qualification quality issues and trends to management.


• Contribute to the periodic Product Quality Review and present on their area of focus during the Management Review meetings.


• Work closely with IT to create a Computer System Master Validation Plan.


• Monitor effectiveness by establishing appropriate quality objectives, metrics, and compliance goals.


• Partner with Product Development, Regulatory Affairs, Clinical Research, external vendors and partners to support corporate objectives and ensure compliance with all quality, regulatory and quality compliance requirements.


• Lead and contribute to site inspection readiness and commercial readiness preparations.


• As an extended member of a Core Development Team, provide input to the team as required.

PERFORMANCE MEASUREMENTS

• 
   Participate in the periodic Product Quality Review meeting and all assigned Core Development Team activities.


• Develop and implement Quality Risk Management (QRM) process to support assessment of complex systems, critical deviations and corrective and preventive actions (CAPA).


• Establish and develop procedures and associated training programs for quality and other functions for risk management and process validation.


• Ensure risk management and process validation design history file documentation are compliant to internal and external regulations and requirements and remain audit ready.

QUALIFICATIONS

EDUCATION/CERTIFICATION:

• Bachelor’s degree in a scientific discipline is required. An advanced degree is preferred.

REQUIRED KNOWLEDGE:

• Working knowledge of ICH risk management tools, Failure Mode Effects Analysis (FMEA), and/or lean/Six sigma concepts.

EXPERIENCE REQUIRED:

• 5 – 10 years medical device and drug quality and regulatory experience in life sciences technology driven company.


• Seasoned professional in managing cGMP Quality Systems (QA and QC) for drug/device products with a thorough knowledge of cGMP regulations (21CFR211, 21CFR820, EMA), ISO 13485, ISO 14971 CE Marking and ICH guidance.


• Experience in oversight of implementing cGMP computer systems with compliance to Part 11 and EU Annex 11 requirements.

SKILLS/ABILITIES:

• Ability to work independently on QA projects and initiatives with minimum supervision.


• Pro-active in identifying opportunities along with strong problem solving and negotiation skills.


• Ability to work "hands on" in an entrepreneurial, fast paced environment.


• Leads by example and highly collaborative with the proven ability to work in a cross-functional team.


• Self-starter and team player with strong leadership, administrative, interpersonal, and team-building skills.


• Strong verbal, written communication skills and computer skills are required.


• Must be goal-oriented, quality-conscientious, and customer-focused.

WORKING CONDITIONS

• No hazardous or significantly unpleasant conditions.