Quality Engineer

Who we are:

Charter Medical, part of the Solesis family of companies, specializes in single-use solutions that enable life sciences innovators to turn bold ideas into lasting breakthroughs, supporting industry-leading companies in bringing life-saving therapies to market. Operating in North Carolina, Charter Medical employs more than 150 team members across two facilities in Winston-Salem.

Guided by a commitment to quality, innovation and customer success, Charter partners with customers to transform promising therapies into commercial realities. Employees contribute to solutions that support life-changing treatments and make a meaningful impact on patients around the world.

1st shift Monday-Friday 8:00 am-5:00 pm

About the role:

The Quality Engineer supports activities related to the successful overall performance of the company’s Quality Management System in support of FDA 21 CFR Parts 210, 211 and 820 and ISO 13485:2016 The incumbent will assist with Customer Complaints, Corrective and Preventative Actions (CAPAs), and Audits.

What you will do:

• Conducts investigations and Root Cause Analysis derived from Customer Complaints, CAPAs, Trending, Out of Specifications, Nonconformances, etc.
• Interfaces with customers to provide reports, data and/or technical support for Products, Complaints, Change Control and Customer Notifications.
• Develops and monitors implementation of Protocols for product evaluation as required.
• Creates, edits and/or revises Test Method Validations, SOPs, WIs, Product Specifications as required.
• Performs Supplier Quality Audits, SCARs (Supplier Corrective Actions) as well as Notifications issuance.
• Assists with Corrective Action system, including but not limited to, administrative duties for database maintenance, serve as CAPA team member or CAPA team leader, facilitate root cause analysis with CAPA teams, ensure CAPA documentation is complete and accurate, perform follow-up evaluation of CAPA effectiveness, and provide trending reports.
• Addresses Customer Complaints, derived investigations, corrective actions implementation, and reporting.
• Assists with hosting, preparing and coordinating external audits and/or Technical Visits as requested.
• Coordinates, implements, and leads activities related to continuous process improvement of the Organization and the Quality System (5S, Kaizen, etc.)
• Assists with ensuring raw materials in process products and finished goods inspected by complaints, CAPA or recall are segregated and dispositioned as necessary.
• Analyzes non-conforming data, including complaint data, for trends and makes recommendations for corrective actions accordingly.
• Accurately and thoroughly responds to customer requests for quality data or quality inquiries.
• Assists with responses to external audits.
• Conducts employee training as required (i.e., GMP, Root Cause Analysis and best practices).
• Supports company goals and objectives, policies and procedures, Good Manufacturing Practices, and applicable FDA, ISO, EU and other regulatory requirements.

• Acts as a Quality ambassador for the company to promote Quality culture.

Who you are:

• Bachelor’s degree (B.S.) in an Engineering discipline.
• Five (5) to eight (8) years of related experience in Life Sciences, Single-Use Technologies & Medical Devices.
• Two (2) to Three (3) years of leading a team or managing direct reports.
• The ability to understand and enforce regulatory requirements.
• Demonstrated working expertise in ISO 13485 and applicable quality-system requirements, including practical application to investigations, audits, product disposition, and quality decisions.
• Knowledgeable in 21CFR820and cGMP’s.
• Demonstrated success managing competing priorities, reducing backlogs, and meeting quality-system and customer deadlines.
• Proven ability to independently lead complex quality activities from problem identification through implementation and effectiveness verification.
• Excellent interpersonal skills with proven ability to get along well with others and work in a team environment.
• Excellent verbal and written communication skills
• Excellent customer service focus and professionalism
• Ability to independently prioritize and execute projects and responsibilities
• Self-starter with the ability to work in a high-paced environment with limited direction.
• Demonstrated ability to establish accountability, exercise sound judgment, and develop a technically capable quality team.
• Demonstrated experience conducting and reviewing root cause investigations using structured problem-solving tools and objective evidence.
• Experience analyzing quality data, reconciling source records, and presenting actionable conclusions to senior leadership.
• Demonstrated experience managing employee performance, including addressing missed commitments and inadequate work quality.

Perks / Benefits:

• Generous Paid Time Off
• Paid Breaks
• Annual Bonus
• 401(k) with excellent company match
• Health Insurance with multiple plans to choose from
• Paid Short Term and Long Term Disability