Medical Devices Quality Assurance Specialist - FDA Cleveland HeartLab
THIS JOB HAS EXPIRED Cleveland HeartLab, Inc. (CHL) is a premier next-generation clinical reference laboratory committed to advancing cardiovascular risk assessment through unique and proprietary diagnostic tests. We focus on novel inflammatory and cardiovascular biomarker technologies that allow for advanced risk assessment.
Due to the growth and success of the company, we are seeking a highly effective hands-on Quality Assurance professional to manage and drive continuous improvement in the quality systems of the company. This role provides an opportunity to make an immediate impact at a high growth, entrepreneurial organization in the dynamic healthcare market. Reporting directly to the Director, Regulatory and Quality Affairs, and located at our corporate headquarters in Cleveland, OH.
Position is responsible for the implementation, monitoring and maintenance of the Quality System in accordance with global IVD regulations. Responsibilities will also include ensuring the Quality System regulations are understood by all applicable company personnel, and is functioning and effective at all times. The scope of the Quality System will encompass all manufacturing processes applicable to IVDs.
The essential responsibilities include:
Draft, review, maintain, distribute and train personnel on facility documentation and procedures, such as the Quality Manual, Quality System Procedures, Quality Assurance Procedures, and Manufacturing Procedures.
Ensure compliance with Design Control, Document Control and Risk Management.
Maintain QSM SOPs, and Documentation Control.
Prepare documentation and systems for compliance with ISO & European requirements.
Ensure compliance with 21 CFR regulations (part 820 cGMP), ISO 13485, ISO 14971.
Conduct and participate in internal and external audits ? FDA inspections, Notified Body, third party QS evaluations.
Participate in CAPA systems. Prepare reports and corrective actions.
Maintain and update the Quality Manual, QA Procedures, and introduce Quality Plan improvements as applicable.
Ensure cGMP compliance with Manufacturing validation processes.
Assist in analyzing and evaluating information concerning manufacturing problems, customer complaints, non-conformances, quality system, etc.
Conduct and maintain post-market surveillance of cleared products.
Trend customer complaints and/or non-conformances.
Assist and/or perform training activities in QM system processes, product quality, and cGMP as necessary.
Confer with Operations (Manufacturing, Product Development, Assay Development, and Reference Laboratory) about quality assurance and regulatory issues of new and existing products to ensure compliance with quality system.
Provide necessary definition, development and deployment of product quality assurance strategy, addressing all phases of product development.
Additional Responsibilities and Tasks:
May serve on designated Project Teams to ensure compliance with company procedures and Quality System Regulation.
Additional duties as assigned.
Job qualifications include:
BA/BS in a scientific field; advanced degree desirable.
Minimum five - seven years related experience in QC/QA in the medical devices/ IVD industry or equivalent.
Strong Quality Systems background, and knowledge of QA/QC principles and compliance.
Knowledgeable about QSR, ISO 13485.
Proven leadership experience.
Superior communication (verbal, written and interpersonal) skills.
Good organizational skills.
Motivated self-starter, ability to multi-task, work independently and also collaboratively.
Aptitude for problem solving, decision making, and an effective cross-functional team participant.
Computer proficient, Microsoft Excel, Microsoft Word, Power point,
Individual must be a confident team player with strong interpersonal skills, an active communicator who can work collaboratively across functions. Individual must possess and exhibit professionalism, energy, high integrity, results orientation and solutions driven.
We offer an excellent benefits package which includes medical, dental, vision, life and disability along with a matching 401K plan.
It is the policy of Cleveland HeartLab to consider candidates without regard to race, color, religion, gender, national origin, ancestry, genetic information, age, disability, or any other condition protected by applicable law. We are a drug free workplace.
||Cleveland, OH |
THIS JOB HAS EXPIRED