The Sr. Manager/Director of Quality Management Systems (QMS) reports directly to the Vice President-Products and is primarily responsible for the implementation and maintenance of a Quality Management System (QMS) in compliance with FDA medical device regulations and EU Medical Device Regulation, and other applicable standards as required.
The role involves building upon an ISO 13485-certified QMS for manufacturing wound and surgical care products device cleared by FDA for sales/marketing in the U.S.
The successful candidate will work within a high-energy, small, focused team environment and maintain a strong sense of shared responsibility and shared reward.
Roles and Responsibilities
- Establishes and maintains QMS procedures and controls ensuring that performance and quality of the product conforms to established company and regulatory standards;
- Provides oversight for product clearances and approvals;
- Assesses QMS effectively through internal audit and Management review and implements corrective/ preventive, improvement actions as appropriate;
- Ensures the implementation of QMS and goals are integrated in a cost effective and productive manner;
- Leads the site staff in the understanding, development and deployment of key strategies, continuous improvement and customer focus;
- Conducts product lot release;
- Document and design change processing;
- Product and process conformity data collection and analysis
- National and international standards representation;
- Product compliance;
- Vendor/ supplier quality assurance inspection and third-party audit management;
- Responsible for IQ/OQ/PQ protocol development and administration;
- Oversees and tracks equipment calibration;
- Complaint administration;
- Product surveillance, field actions, corrections, recalls, and withdrawals
- Perform duties in compliance with Quality Management System and corporate policies.
Minimum Qualification and Experience
- Bachelor’s degree in technical field is required; an advanced degree is preferred
- A minimum of 10 years of overall related business experience in a healthcare regulated environment is required with the preference experience in drug and/or device related industries.
- Minimum 5 years experience in QA/QC; 10 years preferred
- Experience working within/managing a software-based QMS (eQMS) is required.
- Regulatory compliance knowledge and skills are required
- Interpretation and application of QSR and ISO Standards are required.
- Excellent communication and interpersonal skills are required. Statistical and analytical problem solving skills are required.
- The ability to influence at senior levels and across functions, and building strong networks internally and externally is required. Strong experience and proven record motivating leading and developing staff, in a highly changing environment is strongly preferred
- Trained in ISO 13485:2016 (documented certification is preferred)
- Experience with terminally sterilized medical devices and knowledge of ISO 11607 and 11137 is highly preferred
- Previous management experience is highly preferred
- Prior project management experience is preferred
- An ASQ certification (CQE, CQM, CRE or CQA) is an asset
How to Apply
We are a young company that that is agile and nimble. That means you have opportunity to give input and make a difference to how we do things. A “roll up your sleeves and get it done” attitude does well in meeting the challenges of our fast-growing company. Imbed Biosciences Inc. offers a creative and collaborative work environment, with excellent benefits and a casual culture.
To be considered, email your resume with a cover letter to firstname.lastname@example.org.\
About Imbed Biosciences Inc.
Imbed Biosciences is a privately held biotech company emerging as a leader in the development of advanced therapies for burns, chronic ulcers and surgical wounds. The Company has a portfolio of products in research based on its patented Microlyte matrix technology to combat local pain and infections in complex wounds. Imbed is backed by investors and federal agencies, and is building a world-class organization of talented employees and renowned advisors. We offer highly competitive compensation and employee benefits. If you are passionate about improving health care and interested in career growth in a high-energy startup environment, please email email@example.com to meet our stellar team. For more information, visit www.imbedbio.com and follow @Imbedbio on twitter.