The Director of QA will set up the Quality Systems for a start-up medical company and be responsible for the initial recommendations, purchase decisions for critical QA elements including ERP or control software and reporting systems to maintain quality and regulatory compliance at all levels. The Quality Assurance Engineer - Manager will implement, support, and sustain elements of the quality system through procedure generation, training, auditing, and technical support. The quality engineer will be a key resource for ISO, EN, MDD, and QSR requirements, and will provide support to the new product development teams by generating and approving validation studies, capability studies, and by performing FMEA and Hazard analysis. If you meet the minimum requirements summarized below, Click here to apply online

• Responsible for compliance to design control activities, 100% inspection monitoring, sterilization validation, and Class I-III requirements.
• Collaborate with engineering, manufacturing, and regulatory, and work with outside suppliers.
• Support in-house rapid manufacturing operations and provide expertise in statistical process control, and evaluation of control charts.
• Ensure that compliance to cGMP and EN/ISO 13485/MDD requirements are maintained.
• Ensure that all the responsibilities within the scope of this job comply with the scope of the company’s Quality System.

Education Requirements:

• The position requires a Bachelor’s degree in engineering or life sciences

Experience Requirements:

• A minimum of three years experience in the medical device industry.
• Must be able to make decisions related to product quality and release of company products.
• Requires ability to assess current company practices with external standards, guidance, and regulations.
• Must be able to provide and implement solutions to quality problems.
• Requires the ability to understand the impact of GMP’s, ISO 13485, and MDD requirements on company’s new products.
• CQE (ASQC) (recommended).

If you meet the minimum requirements summarized below, Click here to apply online

Related Keywords:

BMA, PRP, DBM, GLP, cGMP, biomaterials, materials, orthobiologics, “bone marrow”, CQE, ASQ, QSR, “design control”, “quality system”, FDA, ISO, ISO 9001, “Knee Implants”, Laparoscopy, Laser, Lasik, Mammography, Microscope, “Minimally invasive surgery” products, MRI, Navigation, Neurostimulators, Ophthalmic lasers, Orthopaedic implants, Orthopaedic reconstructive products, PACS, PET, Phaco Emulsifier, Plates and screws, Radiation Oncology, Recruiter, Ring fixators, Robotics, Sales, Search, Spinal implants, Spine cage, Stapler, Stent, Stereotactic, Sterilizer, Surgical instruments, Surgical navigation, Surgical Robotics, Suture, Tissue expanders, Total Joints, Trauma implants, Vertebral Implants, YAG, Orthopedic, TKA, TKR, cranial, knee, hip, engineer, engineering, quality, regulatory, VP, director, business, sales, verification, testing, “quality assurance”, “class I”, “class II”, “class III”, “class 1”, “class 2”, “class 3”, “class 1,2,3”, “custom implant”, biomedical, biotechnology, bioengineering, biomechanics, senior