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.