Regulated QA

We are looking for a Regulated Quality Professional to join our PharmBIO Quality team in Elkton, Maryland. This role ensures quality system compliance across PharmBIO's businesses and shared processes, serving as a key Quality System Representative for product teams. The position involves monitoring and improving quality system processes, supporting audits, and collaborating cross-functionally to uphold regulatory standards and drive continuous improvement.

This position offers a hybrid work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore's work arrangement policies.

Pay and Benefits:

• $85,000 - $107,000 per year
• Factors considered in extending an offer within this pay range include (but not limited to) education, experience, knowledge, skills and abilities.
• Medical, Dental and Vision benefits effective on Day 1 of employment! We offer a comprehensive total rewards package, including competitive benefits. More details are available at www.gore.com/careers/benefits

• Serve as Quality System Representative for product teams and shared PharmBIO quality system processes to ensure appropriate compliance as it relates to systems, processes, products, improvements, and modifications
• Assure all Quality System documentation and record keeping activities are carried out and completed in compliance with established procedures and work instructions
• Participate in internal, external, and supplier audits, as needed
• Ensure appropriate Quality System process monitoring and trend response (Complaints, Training, CAPA, etc.)
• Write and revise documents and process through change control system, as required
• Assure Quality Systems compliance with internal procedures and external standards while identifying and driving key quality system process improvements
• Partner with cross-functional teams including, but not limited to, procurement, engineering, manufacturing, and regulatory affairs
• Maintain compliance with training expectations as required for this position
• Additional responsibilities as required within the scope of position

• Bachelor's Degree or a minimum of 4 years work experience in manufacturing, supply chain or technical
• Demonstrated critical thinking (ability to understand the applicable standards, ensure compliance to them and identify opportunities to improve)
• Strong interpersonal skills (ability to teach and gain compliance alignment cross functionally)
• Demonstrated mindset of continual improvement and track record of defining and achieving the desired future state
• Demonstrated sound business judgment and decision-making skills. Track record of keeping commitments, owning, and driving improvements, and getting solid, tangible results.
• Strong written communication skills
  
• Ability to travel up to 10%

• Experience working in an ISO13485 Quality Management System
• Experience participating in quality audits as an audit team member, or in support of customer/external audits
• Experience applying problem solving methodologies (5-why/Factor Tree Analysis, Fishbone/Ishikawa diagrams, A3 Problem Solving)