The hands-on Quality Manager will be responsible for managing a team of quality professionals assessing the performance of people and guide them for further individual development and setting goals for the function. Responsibilities include developing and implementing systems to ensure products are designed and produced to meet Quality specifications.
- Ensure the Quality System is effectively established, implemented and maintained in accordance with applicable standards.
- Develop and support design transfer activities by implementing standardized quality centric launch practices that enable business strategies.
- Create and promote Quality and regulatory awareness level as determined within the organization.
- Act as a contact person for ongoing NPD Projects to make sure to provide right amount of resources.
- Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle.
- Ensure compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.
- Manages the review and approval of finished products manufactured for and by the company in accordance with their approved specifications.
- Oversee all inspections and questions relating to the Quality operation of our contract manufacturer.
- Manages product recall activities to include recall policies and procedures for the company. Additionally, manage product compliant activities and processes.
- Support and attend to internal and external Audits for the organization.
- Author, review and approve SOPs, protocols, reports, and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards, and IRRAS internal procedures.
- Manage IRRAS Quality events – deviations, non-conformances, CAPAs, customer complaints, process change controls, recalls, etc.
- Evaluate deviations, non-conformances, out of specifications, customer complaints and process change controls for completeness and impact on product quality.
- Review, consult, and approve risk analysis performed for COs, NCMRs, recalls, etc.
- Work with operations on the implementation of process programs and controls.
- Investigate and works with other departments to resolve quality issues related to area assigned.
- Oversee internal and external compliance audits.
- Review records and data for product release.
- Oversee Quality system training and lead development of training programs regarding all aspects of producing quality products.
- Performs trending of established quality metrics.
- Serves as Management Representative on all Quality functions.
- Act as an agent of positive change, innovation and continuous quality improvement, with the ability to influence across functions.
- Plan and schedule projects in a manner consistent with corporate objectives.
- Work with product development staff to ensure that products under development are compliant with FDA and ISO requirements.
- May perform additional duties as assigned or directed by management from time to time
EDUCATION & EXPERIENCE:
- Bachelor’s degree in life science or related field or the equivalent combination of education and/or experience. Engineering degree preferred.
- 5-10 years’ quality experience in biotech or Medical Device/IVD industries (GMP regulated environment) working in a Quality Assurance role, with 5 years’ experience leading teams or people.
- High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.
- Excellent communications and presentation skills.
- Ability to develop and manage a high-performance team focused on accountability and meeting and exceeding expectations.
- Ability to lead, influence, create and work within cross-functional team environments.
- Assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude and a sense of urgency to get things done.
- Performance Orientation – Is driven by personal performance; achieves all objectives detailed in IRRAS Department goals and comfortable with quantifiable assessments.
- Impact Orientation – Performs to stated objectives and driven to make an impact on company goals and patients’ lives.
- Competitive – Dedicated to a competitive spirit that supports the IRRAS goal to be the premier Medical Device company in the industry.
- Sense of Urgency – Has the speed and agility dedicated to the company’s goals and performance.
- Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability maintain composure and focus in situations of ambiguity and uncertainty.
- Confidence – Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to finish especially in the face of resistance or setbacks.
- Multitasking – Capable of performing multiple tasks over a certain period of time by executing them concurrently.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.
- The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Transition from standing and sitting often.
- Required specific vision abilities might include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee might occasionally lift and/or move up to 25 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- General office environment.
- Daily exposure to PCs and networks.
- The noise level in the work environment is usually moderate.
- Travel will be required.
The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
If you are interested in applying for employment at IRRAS please apply here.