Associate Quality Engineer (Friday-Sunday)
Associate Quality Engineer (Friday-Sunday)
At MiMedx, our purpose starts with helping patients heal. We are driven by discovering and developing regenerative biologics utilizing human placental tissue to provide breakthrough therapies addressing the unmet medical needs for patients across multiple areas of healthcare. Possessing a strong portfolio of industry leading advanced wound care products combined with a promising clinical pipeline, we are committed to making a transformative impact on the lives of patients we serve globally.
POSITION SUMMARY:
Qualify equipment and validate processes and systems used to process tissue, biologic drug or medical device products. Ensure compliance with all applicable principles, regulatory requirements, company policies, and standards. Provide Operations support for equipment and completion of any additional equipment-related corrective actions, etc. Coordinate with other quality engineers for equipment support. Position does include travel between facilities (approximately 8-10 miles).
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Develop, write, and execute equipment qualifications of limited complexity and scope with oversight from senior personnel
Generate and resolve protocol discrepancies and/or deviations that may arise as part of equipment qualification execution
Responsible for release of equipment in the equipment database
Responsible for verifying equipment following work order completions (movements, preventive maintenances, reactive maintenances, etc.) to ensure equipment has been returned to its qualified state.
Introduction and gradual independent performance of projects, efforts, and changes of limited complexity and scope under supervision/mentoring of senior personnel
Assist and support validation activities and process development activities wherever needed
Participate in continuous improvement activities that directly impact performance measures
EDUCATION/EXPERIENCE:
BS degree in Science, Engineering, or related field
0-3 years of experience working in an FDA-regulated industry
Knowledge of GDP
Prefer cGMP pharmaceutical industry, biologics industry experience; medical device or tissue processing industries considered
Knowledge of FDA, AATB, ISO, and other state/federal/international regulations and standards
SKILLS/COMPETENCIES:
Excellent oral, written, and interpersonal communication skills
Proficient in Microsoft Office (Excel, Word, etc.) and Minitab
Organized, flexible, and able to multi-task while maintaining a high level of efficiency and attention to detail
Must show aptitude to develop appropriate skills needed for the job
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)