Are you a problem solver with an uncompromising eye for Quality? Do you thrive on working in a fast-paced environment? Are you an excellent communicator and team member? Do you exemplify our core values of Humility, Integrity, Hunger, and Accountability? If so, then we want you on the Imbed Biosciences team!Job Summary
The Director of Quality Management Systems
(QMS) reports directly to the Vice President-Operations and is primarily responsible for the implementation and maintenance of a Quality Management System (QMS) in compliance with FDA medical device regulations, EU Medical Device Regulation, ISO, and other applicable standards as required.
The role involves building upon an established ISO 13485-certified QMS for manufacturing wound and surgical care products device cleared by FDA for sales/marketing in the U.S and select foreign countries.
The successful candidate will work within a growing, high-energy, focused team environment and maintain a strong sense of shared responsibility and shared reward.Roles and Responsibilities
Minimum Qualification and Experience
- 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;
- Work with interdisciplinary team in a collaborative way to maintain quality compliance and achieve company goals;
- Conducts product lot release;
- Document and design change processing;
- Product and process conformity data collection and analysis
- National and international standards representation;
- Product and process compliance;
- Vendor/ supplier quality assurance inspection and third-party audit management;
- Accountable for IQ/OQ/PQ protocol development and administration;
- Oversees and tracks equipment calibration;
- Product surveillance, field actions, corrections, recalls, and withdrawals;
- Lead the growth of the Quality department to accommodate commercial growth;
- Perform duties in compliance with Quality Management System and corporate policies.
WHY YOU SHOULD APPLY:
- 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 required
- Prior project management experience is preferred
- An ASQ certification (CQE, CQM, CRE or CQA) is an asset
Imbed Biosciences, Inc. is a growing Medical Device company with commercial products being sold in the U.S. and overseas and with many exciting products in the development pipeline. In fact, we are growing so quickly that we are relocating in Q2 2022 from our current Fitchburg, WI, location to a brand new, larger, completely redesigned location in Middleton, WI!
At Imbed, we understand the mounting pressures on our current and future employees' families because of the COVID-19 pandemic. We offer flexibility, excellent salary and benefits, professional growth and development, and a team that will propel you to succeed!
If you are looking for a place to grow, thrive, innovate, make a difference in patients' lives, and enjoy the work you do, then we want you on the Imbed team!