- Spinal Fusion
- Long Bone Repair
- Osteochondral Repair
- Dental and Facial Bone Repair
- Immuno-Oncology
- Establish quality systems/policies related to OOS, Deviations, CAPAs, NCMRs, and Complaints and work with various departments to ensure timely closure of related investigations. Document deficiencies, including root cause, corrective and preventive action plans. Ensure action plans are implemented in a timely manner.
- Support from a quality perspective, analytical test method qualification plans/protocols and reports.
- Assist with risk analysis activities and maintaining up to date risk management documents.
- Establish Quality Inspection Plans for the release of components, assemblies, and finished devices. Conduct quality inspections as needed.
- Support Manufacturing and R&D/Product Development, Analytical Development and Quality Control with statistical techniques, including design of experiments (DOE); sampling plans and data/ results analysis.
- Utilize statistical techniques, including design of experiments (DOEl and sampling plans to analyze results effectively
- Support quality management programs such as supplier selection and certification. Perform supplier evaluations as needed to assure supplier capabilities including the assessment of the adequacy of inspection methods, manufacturing practices, and control and quality procedures to deliver conforming products in a timely manner.
- Lead supplier audits and works with suppliers to resolve audit findings and/or nonconformances.
- Perform internal audits as needed.
- Responsible for quality engineering review of Document Change Orders.
- Review specifications for products or processes.
- Set requirements for raw material or intermediate products for suppliers and monitor their compliance.
- Ensure adherence to regulatory requirements, and health and safety guidelines.
- Supervise inspectors, technicians and other staff and provide guidance and feedback.
- Quality oversight on all product development procedures to identify deviations from quality standards.
- Quality oversight on all product manufacturing processes and systems
- Quality oversight on all manufacturing output and ability to compare properties to requirements.
- Quality oversight on the sterilization and product release processes.
- Minimum of a BS in Biomedical Engineering, Chemical Engineering, Biochemistry, Chemistry, or equivalent degree.
- 5+ years relevant experience in Biologics, pharmaceuticals, and/or medical devices and combination products.
- Must be fluent in reading, writing, and speaking Japanese.
- Must have a understanding of regulatory requirements for one or both of the following:
- the medical device industry, specifically 21 CFR 820, ISO 13485, and ISO 14971
- the Biologics/ Pharmaceutics industry, specifically, 21 CFR 211 and ICH Quality Guidelines.
- Highly motivated and self-directed with a strong sense of urgency, with an ability to pull in resources from other departments as required.
- Must be able to interface well with Management, Manufacturing and R&D/Product Development, Analytical Development and Quality Control.
- Ability to deliver, meet deadlines and be results oriented.
- Detail-oriented, thorough, observant.
- Excellent Communications Skills (oral, written, presentation) at different organizational levels.
- Experience with statistical techniques and tools.
- Experience with root cause analysis tools and methods.
- Certification(s) in quality engineering (e.g., ASQ Certified Quality Engineer) is a plus.
- On-site at Theradaptive corporate headquarters and laboratory in Frederick, MD.
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Senior Quality Engineer - Frederick, United States - Theradaptive
Description
Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in the area of regenerative medicine, working at the interface of Biology and Orthopedic tissue repair.
Our lead therapeutics are in the following indications:
POSITION SUMMARY:
We are seeking a talented Senior Quality Engineer who is fluent in Japanese and English to ensure that the highest standards of quality and compliance are met for our organization. This position will play a pivotal role in establishing and maintaining robust quality systems and processes to support our first-ever clinical trials through to our manufacturing processes. Working closely with cross-functional teams, this person will be responsible for implementing quality standards, conducting risk assessments, and driving continuous improvement initiatives to ensure compliance with regulatory requirements and industry best practices.
This role will provide leadership on quality aspects on a daily basis by developing, establishing, and maintaining quality engineering methodologies, systems, and practices.
The ideal candidate will have experience in Quality Assurance within the biotechnology or medical device industry. They will be involved in implementing Quality Management Systems, developing risk management plans, supporting product development, maintaining SOPs, and will be fluent in reading, writing and in speaking Japanese.
RESPONSIBILITIES:
Theradaptive is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, ethnic or national origin, ancestry, pregnancy (including childbirth or related condition), citizenship, familial status, mental or physical disability, veteran status, genetic information, other non-disqualifying disability, or any other characteristic protected by law.
