If you are interested in working for a growing company that will stretch your skillset consider ACell!
Our regenerative lines of products are innovative and cutting edge. Our culture is entrepreneurial,
collaborative, and fun. At ACell we work hard but we make time to celebrate individual and team successes. If you are looking to work alongside highly experienced professionals in their fields this is the company to join.
Title: Quality Engineering Manager
Location: Columbia, MD
Reports To: Senior Director of Quality
Manages facility’s Quality Engineering activities and processes. Supports the management and continuous improvement of the Quality Management System (QMS) processes, maintenance of the Medical Device quality system, and quality procedures in accordance with FDA 21 CFR Part 820, ISO 13485:2003, MDSAP, MDD/MDR, CE Mark, state and local regulations, and ACell policies and procedures.
Manages Quality Engineers and functions (MD and/or IN)
· Maintains Quality metrics in databases and prepares trends and graphs as needed
· Manages QC equipment qualifications, quality process optimization, and quality test method validations
· Actively supports Product Development and Manufacturing Engineering projects and validations
· Administers elements of the site quality system in relationship to the corporate quality system and make revisions as needed
· Manages the Change Control Process
· Manage the Supplier Quality Process
· Support internal and external Quality audits
· Develop, execute, and analyze quality reporting metrics
· Takes a leading role with managing the company’s Risk Management Process
· Takes a leading role with administrating the companies CSV, software validation and data integrity processes
Required Education and Experience
· Bachelor’s degree in a related scientific discipline
· Minimum of 5 years of experience in Quality within a pharmaceutical, medical device, biologic, tissue bank, diagnostic, hospital, or similar organization
· At least 2 years in a management /supervisory role preferred
· Minimum of 2 years of experience participating in equipment qualification and process validation protocols and reports, and executing validation protocols
Required Knowledge, Skills, and Abilities
· Six Sigma, CQA, and CQE preferred
· Demonstrated organization skills
· Must possess strong leadership skills with team-focused attitude
· Strong analytical skills
· Experience with device packaging and sterilization validation preferred
· Demonstrated knowledge of cGMP, Quality System Regulation 21 CFR Part 820, ISO 13485:2003, and other national and international regulations and standards
· Strong communication skills, both written and verbal
· Computer literacy – experience with MS Outlook, Word, Excel, and Access database
· Management and/or interaction with multilevel staff
· Must be able to occasionally lift up to 40 lbs
· Office environment except when traveling
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All qualified applicants will receive consideration for employment, transfer or promotion without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability or veteran status.