DiaPharma now hiring QA / RA Manager
Posted: October 3, 2023
Quality Assurance & Regulatory Affairs Manager
DiaPharma Group, Inc. – West Chester, Ohio
Hybrid – three days per week onsite
DiaPharma Group specializes in laboratory assay kits, reagents, and instrumentation for research and clinical applications in the fields of coagulation, platelet function, bleeding and clotting disorders, cell death, liver injury, and oncology. We deliver solutions and support to our customers.
Our in vitro diagnostic test kits and instruments are used in hospital laboratories, clinical reference laboratories, universities, and pharmaceutical companies. Our line of research products is used by researchers and medical corporations for product development, clinical research studies, and in quality control laboratories.
We seek a seasoned Quality Assurance – Regulatory Affairs Manager to manage quality systems, processes, and procedures to assure product safety and quality. This individual will drive business alignment to correct industry requirements by managing quality system design, controls, and continuous improvement.
Key responsibilities include:
- Serve as Management Representative.
- Promote audit readiness, prepare company for inspections by external bodies, including FDA, Health Canada, and customers, and facilitate audits and inspections.
- Own and manage quality systems, processes, policies, and procedures to assure product quality and safety across the business.
- Engage strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs).
- Influence and track quality system metrics such as Corrective and Preventive Action, training metrics, and complaint resolution metrics.
- Ensure compliance to FDA and Health Canada regulations.
- Ensure/follow up/implement corrective actions that are raised by deviations, internal audit, or regulatory inspection.
- Spearhead and prepare regulatory submissions and perform regulatory activities, such as 510(k) and de novo submissions.
- Other duties as assigned.
- Bachelor’s degree or higher.
- 3 to 5 years of experience working in the medical device industry, specifically in area of Quality Assurance and Regulatory Affairs.
- Experience with in vitro diagnostics (IVDs) a plus.
- Demonstrated knowledge of medical device quality system regulations (e.g. QSR, ISO 13485, MDSAP), including Design Control, DMRs/DHFs, CAPA, Complaints, Risk Management, Document Control, Training, Complaint Handling, and Audits.
- Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner.
- Experience with the following:
- Preparing FDA submissions, license applications, registrations and other product approval documentation.
- Analytical & problem-solving skills/root-cause analysis.
- A competitive salary.
- Generous PTO and paid holiday schedule.
- Abbreviated Friday schedule.
- Superior medical, dental, life, STD & LTD insurance.
- 401(k) participation with generous match.
- Supportive work environment.
- Continuing education and training opportunities.
* Benefits may be subject to eligibility requirements and waiting period.
DiaPharma Group, Inc., provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
This employer participates in E-Verify.
For consideration, please forward your resume to email@example.com.