Quality Systems Director Jobs in Manchester, NH at DEKA Research and Development Corporation
Title: Quality Systems Director
Company: DEKA Research and Development Corporation
Location: Manchester, NH
Salary: $80K – $100K*
Category: Pharmaceuticals & Biotech
DEKA employs a team of over six hundred professionals, whose engineering, design, manufacturing and quality expertise make DEKA a hot spot for creating innovative solutions and advanced technologies. Located about an hour from Boston, the beach, and the mountains, DEKA is one of the leading research and development companies in the country and is the birthplace of some of the most innovative and life-changing products of our time.
We are seeking a Quality Systems Director to develop, implement and improve an effective quality system designed to meet appropriate Business, Government and international standards for efficacy, safety and quality. In this role you will be responsible for planning and implementing the Quality System strategy. This role will ensure programs are consistent in complying with FDA QSRs, ISO 13485, and standards for Medical Device products in support of Clinical and Research applications. This position is responsible for overall management of internal audits, regulatory inspections, Notified/Certification Body audits, corrective and preventive actions, document controls, training, metrics reporting, and implementation of new technologies for QS efficiencies.
How you will drive change:
Function as the Management Representative
Develop and deliver Management Review presentations. Ensure follow up on action items, including collecting and evaluating metrics, and presenting information to Executive Management. This includes collection of all data necessary to conduct Management Reviews
Develop and implement quality information reporting systems and administer FDA, ISO 13485 standards including audits, certification and the Management Review process.
Plan and direct resources and activities of the QS functions, which includes responsibility for the internal audit program, CAPA, document controls, training, post market surveillance and management controls.
Promote, develop and manage continuous quality improvement activities through effective utilization of the CAPA system
Manage all FDA inspections, ISO audits, 3rd-party audits, corporate audits, and any other regulatory assessment.
Ensure adequate and effective auditing of quality systems.
Design and develop procedures and processes for recording, collecting, evaluating, and reporting quality data associated with the Quality Systems.
Carry out people management responsibilities such as hires, job assignments, coaching, transfers, promotions, salary actions, and performance reviews
Develop and provide quality system training for the DEKA organization
Develop strategies for more efficient QS platforms through technological means, such as electronic DHFs, electronic change control, data analysis tools, and streamlined approaches for efficiencies within the QS.
What you need:
Education: Requires a BS in a related scientific or engineering discipline.
Licenses or Certification: Professional certification is an advantage (i.e, CQA, CQE, SQE, CQM, Six Sigma)
Significant experience in FDA regulations and ISO requirements. Ideally previously involved with remediation activities within manufacturing and design.
Effective communication and presentation skills.
Demonstrated ability to motivate and manage exempt and non-exempt Quality System personnel.
Effective analytical, technical and problem solving skills. Ability to perform multiple tasks and prioritize workload.
Ability to effectively manage conflict and constructively c…