Quality Assurance Manager (Full-Time or Contract-to-Hire Position)
About the Opportunity
The Quality Manager will be a key member of the QA organization of a growing medical device company developing and manufacturing devices and platforms for the assessment and management of Traumatic Brain Injury (TBI). The position will manage Quality Assurance activities related to product development, new product introduction, and manufacturing and provide leadership in fostering a culture of continuous improvement.
Reports to Director, Regulatory Affairs, Quality Assurance & Compliance
Is a contract or full-time position based in our corporate office, located in Bethesda, Maryland.
Maintains a customer focus, a commitment to excellence, and adherence to compliance policy and medical device regulation in all work decisions to uphold BrainScope’s “Culture of Quality.”
For full-time roles, we offer a competitive salary and commission pay, strong benefits and stock options to complete the package.
Manage, improve and maintain quality methodologies, processes and procedures. Lead continuous improvement initiatives and projects to improve processes and upgrade BSC quality documentation electronic system to meet expanding quality activities for commercialization.
Establish and maintain effective cross functional team communications to advance quality.
Develop master plan for BSC quality initiatives, and coordinate, manage and track QA team’s efforts, ensuring milestones are met within defined budgets and schedules.
Manage and coordinate inspection, sampling, testing, and/or packaging of supplies/components and finished products per established quality specifications.
Assist with improving key company quality sub-systems such as supplier management, production and process control, risk management, CAPA, NCMR, and complaint handling and assure that best practice software development lifecycle process is established and maintained
Participate in department and inter-department planning and management teams and work cross-functionally to improve processes within the BSC organization.
Develop and trend key metrics to monitor the health of various quality sub-systems and overall quality system. Compile and analyze data, and document, summarize and report quality findings to senior/executive management and new product development teams, and recommend appropriate actions.
Coordinate BSC activities for any external audits and inspections, including FDA, MDD, MDR, MDSAP and ISO13485. Maintain and ensure effective standard operating procedures are in place for Medical Device-related auditing and inspections. Establish and conduct audit and inspection readiness training for all BSC parties and ensure readiness through other means such as mock audits. Conduct 3rd party audits to ensure adherence to BSC requirements.
Ensure compliance and employee adherence to internal SOPs, policies, external regulations (e.g., 21CFR 820 and ISO13485) and established best practices. Ensure product development and design control activities, including verification and validation, are performed in compliance with internal procedures and standards.
Partner with R&D, Engineering, Clinical, etc., in the development of new products including establishing standards for these products. Provide input on content and quality of product requirements, design, and test protocols.
Develop or approve recommendations to change systems, policies, and procedures; ensure timely and accurate implementation. Assure systems are in compliance with ISO and FDA quality system regulations. Responsible for understanding, tracking and complying with external regulations and standards and updating procedures to conform to latest versions.
Manage Quality Assurance team. Define priorities, delegate responsibilities and balance planning efforts with day-to-day demands. Identify and obtain staff capabilities needed to accomplish objectives. Responsible for ensuring that department understands and complies with quality standards and requirements, as documented.
Oversee and handle various short and long-term QA-related projects, and support or lead other tasks and responsibilities, as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Bachelor’s Degree in Mathematics, Business, Computer Science or Engineering
5+ years’ experience with FDA and ISO regulated product development and ISO quality systems, including Design Controls, Production and Process Controls, CAPA and complaints
Experience with ISO 13485, as well as FDA, Health Canada, TGA and/or other medical device regulation.
Must have 2 years managerial experience in a quality assurance position
Proven track record of success building, leading, and managing a functional and technical QA team
Experience with risk analysis and risk management.
Extensive experience championing quality and quality initiatives
Experience with software validation and software hazards analysis preferred
High attention to detail and meticulous record-keeping
Ability to work both independently and as part of a highly integrated team
Multitasking and project organization skills a must
Excellent communication and problem solving skills
Comfortable working in a fast-paced start up environment
Qualified applicants are encouraged to send their resume and a cover letter including availability to firstname.lastname@example.org.
The Office of Federal Contract Compliance Programs (OFCCP) has released a Voluntary Self-Identification Form CC-305. All federal contractors are required to use this form in inviting all applicants and employees to provide information regarding their disability status. Completing this form is voluntary and any answer you give will be kept private and will not be used against you in any way. If you choose to complete the form, please attach it with your job application. The form can be found at https://www.dol.gov/ofccp/regs/compliance/sec503/Self_ID_Forms/VoluntarySelf-ID_CC-305_ENG_JRF_QA_508c.pdf