The successful candidate will significantly influence the company's compliance with quality system regulations and standards, particularly in evidence-based and scientifically-proven product areas such as product inspection, engineering design controls, and design change controls.

ONSITE Job - Birmingham, AL (Not open to remote or hybrid.)

Responsibilities/Qualifications MUST HAVE

• 2 years in FDA-regulated environment with technical specs and documentation.
• Providing support to New Product Development (NPD) teams regarding 21 CFR Part 820, Part 1271, and associated EU/Canadian standards.
• ASQ Certified Quality Engineer experience.
• Knowledge of regulatory medical device and international quality standards.
• Experience with Electronic Quality Management System software (e.g., ETQ Reliance).

Responsibilities, continued

• Investigating and supporting individual customer product complaints by summarizing and reporting results.
• Ensuring compliance with the Quality System through policy establishment and controlled documents.
• Conducting Process Validations, including necessary risk management activities.
• Providing support to New Product Development (NPD) teams regarding 21 CFR Part 820, Part 1271, and associated EU/Canadian standards.
• Managing nonconforming material and supporting daily Material Review Board (MRB) activities.
• Establishing, documenting, and maintaining the company's document control system, including change control and record-keeping.
• Assisting Research & Development with reviewing and approving design inputs.
• Overseeing regulatory and manufacturing standard reviews to ensure State of the Art compliance.
• Documenting, releasing, and communicating changes to company supplier quality assurance policies and procedures.

Qualifications, continued

• 2 years in FDA-regulated environment with technical specs and documentation.
• Proficient in Microsoft Windows and Office applications.
• Excellent reading, writing, and verbal communication skills.
• Knowledge of regulatory medical device and international quality standards.
• Professional interaction with colleagues and suppliers.
• Experience with Electronic Quality Management System software (e.g., ETQ Reliance).
• Bachelor's degree preferred or equivalent experience.
• ASQ Certified Quality Engineer certification preferred.

Benefits

• Relocation candidates will be considered.