Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 10-15+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.
Quality Operations Manager – direct hire / full-time
Director, QA & RA
Allen, TX 75002
Manages the activities of the Quality Control (QC) staff and activities to ensure that Company operations remain in compliance with all supporting systems as per regulations. Provides leadership, strategic thinking, and results focus to reliably meet and/or exceed the Company production targets while achieving high levels of quality.
Bachelor’s degree in a technical or scientific discipline is required.
A minimum of ten years of experience in a quality or regulatory position, preferably in the medical device industry. Experience with EO sterilization processes, sterile product assembly and packaging, and electronics assembly preferred.
A minimum of three years of management experience or five years in a quality leadership role.
Excellent working knowledge of the FDA’s 21 CFR Part 820; ISO 13485; EU Medical Device Directive (93/42/EEC); Canadian Medical Devices Regulation (SOR98-282); Japanese MHLW Ordinance 169; RDC ANVISA 16/2013, Australian TG(MD)R, ISO 14971, ISO 9001, and Medical Device Single Audit Program (MDSAP). Experience with IEC 60601 preferred.
Experience in supporting FDA inspections as a quality system subject matter expert and an ability to interpret regulatory requirements.
Detail oriented and possess a professional demeanor, be adaptable to changing environments, handle diverse workloads, and capable of completing tasks with little or no supervision.
Ability to travel to any supplier or customer facility, domestic and internationally, when necessary.
Demonstrated ability to work in a highly cross-functional environment.
Advanced computer skills to include MS Excel, MS PowerPoint, and MS Word.
Excellent written and verbal communication skills are required and must be able to read, write and understand complex subjects. Technical writing experience within a medical device environment is essential.
Excellent technical writing experience within a medical device environment is essential.
The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.
Strong root cause analysis skills.
Ability to use sound scientific judgement and risk management for the facility to prevent regulatory action.
The ability to work with minimal supervision to prioritize tasks and be able to manage several projects and tasks simultaneously to meet deadlines; and the ability to interface with all levels of management.
Certified Lead Auditor or ASQ certification as a Certified Quality Auditor (CQA), Certified Quality Engineer (CQE) strongly preferred.
Manages the personnel activities of the Quality Control staff, including recommendations related to resource needs, training, and personnel development. Provides feedback on staff performance via performance reviews, and mentorship to continually improve staff skills and effectiveness.
Supports Manufacturing and Inspection/Test operations during production, ensuring unexpected events are handled compliantly and in a timely manner.
Trends and monitors and trends key performance indicators as related to the Quality Control operations.
Develops and validates test methods, performs data analysis, and writes/revises SOPs.
Reviews and approves documents, including Device History Records, Standard Operating Procedures, Validation Protocols and Reports, Deviations, Engineering Change Requests, and Non-Conforming Materials Reports, CAPA Reports, Complaint investigations and Supplier Corrective Action Reports to ensure operational support and compliance.
Manages the environmental monitoring program in applicable production areas.
Leads and/or provides support to failure investigations of internal non-conformances and CAPA projects.
Leads and/or provides support to project teams to ensure verification and validation activities are being adequately performed and documented.
Acts as sterilization Subject Matter Expert. Responsible for making decisions related to introduction of new/modified products to the existing sterilization validation, sterilization process improvements, failure investigation, requalification, and validation. Conducts supplier audits and makes sterile lot release determinations.
Develops and executes quality control plans for each product line.
Develops process capability studies for current and new manufacturing processes to establish and track cost of inspection.
Strives to continuously innovate and improve methods and processes. Defines optimum approaches in testing and analyzing data for each test being performed.
Acts as assistant to Management Representative during customer and regulatory audits. Participates in regulatory inspections and customer audits.
Qualifies new suppliers as needed and perform routine supplier monitoring activities.
Conducts internal audits to verify compliance to regulations.
Notables / Benefits:
Mid-size company with great company culture that is well diverse
Have a voice in the company
Average tenure for employee population is 10-15+ years
401k with employee matching available
Paid vacation, health/dental/vision, and other excellent benefits