Quality
Jump to Listing: Quality Engineer - Medical Devices
Jump to Listing: Quality Control Inspector - Medical Devices
Jump to Listing: Quality Control Inspector - Medical Devices
Quality Engineer - Medical Devices
About the Job:
SpineCraft develops and manufactures spine surgery implants & instruments systems that provide comprehensive spine care solutions to improve and enhance quality of life for patients with back pain, neck pain, degenerative disc conditions, spine deformities and injuries due to trauma.
We are seeking a highly motivated Quality Engineer to work in a fast-paced environment that fosters teamwork, change, risk-based decision-making and flexibility. The Quality Engineer will support all new spine implants & instruments development activities and associated manufacturing processes and will actively participate in continuous improvement and support activities of existing products. This individual will develop and improve on risk assessment, inspection methodology and acceptance criteria for inspection sample plans and conduct audits of new suppliers as part of the project teams. The Quality Engineer will be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Operations & Manufacturing, and Marketing.
PRIMARY FUNCTIONS & RESPONSIBILITIES:
Bachelor’s degree in Mechanical or Manufacturing Engineering is required. Master’s Degree is preferred.
SpineCraft offers a generous compensation and benefits package that includes comprehensive medical and dental insurance benefits plus a 401K retirement plan. Salary is competitive and commensurate with experience.
About the Job:
SpineCraft develops and manufactures spine surgery implants & instruments systems that provide comprehensive spine care solutions to improve and enhance quality of life for patients with back pain, neck pain, degenerative disc conditions, spine deformities and injuries due to trauma.
We are seeking a highly motivated Quality Engineer to work in a fast-paced environment that fosters teamwork, change, risk-based decision-making and flexibility. The Quality Engineer will support all new spine implants & instruments development activities and associated manufacturing processes and will actively participate in continuous improvement and support activities of existing products. This individual will develop and improve on risk assessment, inspection methodology and acceptance criteria for inspection sample plans and conduct audits of new suppliers as part of the project teams. The Quality Engineer will be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Operations & Manufacturing, and Marketing.
PRIMARY FUNCTIONS & RESPONSIBILITIES:
- Participate in the evaluation and approval of contract-manufacturers/suppliers.
- Participate in conducting suppliers’ audits as required.
- Ensure that vendors Process FMEA is compliant with ISO 13485 and cGMP requirements.
- Help develop, qualify, and validate methods of inspection, testing, and evaluation.
- Help establish internal and external inspection requirements.
- Review, approve, and implement inspection plans.
- Support product design transfers to contract-manufacturers/Suppliers.
- Work with suppliers to establish & manage required gages.
- Participate in risk analysis activities at different phases of products development, production and commercialization.
- Participate in the review and approval of Engineering Change Orders and the review and approval of detailed drawings.
- Participate in Product Design Verification & Validation.
- Participate in analyzing customers complaints to determine root cause.
- Participate in handling MDRs.
- Participate in reviewing collected data and trends to make them available for the periodic update of product Risk Management.
- Participate in maintaining and monitoring the following quality systems and supporting documentation:
- Audit system
- CAPA system
- FDA QSRs system
- ISO 13485 system
- Participate in the review, update, and implementation of procedures affecting quality assurance.
- Participate in the review of external reference documents related to the company Quality Management System to ensure that necessary updates are applied to the company procedures and implemented.
- Participate in developing internal training sessions on quality and compliance issues as necessary.
- Must have 6+ years Quality Engineering experience with at least 4 years in orthopedic, spine or similar surgical products setting. Validations experience a plus.
- Working knowledge of FDA QSRs, ISO 13845, MDD & other international medical device regulations, and the application of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, SPC, and Root Cause Analysis.
- 2D & 3D CAD (SolidWorks and/or ProEngineer) experience is a must.
- Ability to effectively work cross-functionally with Product Development, Operations and Marketing
- Excellent problem solving and troubleshooting skills.
- Excellent interpersonal and communication skills.
- Must be positive, energetic team player, and an advocate for product excellence and quality.
- Candidate must be results oriented, quick learner, respond to the urgent needs of the team and show a strong track record of meeting deadlines.
Bachelor’s degree in Mechanical or Manufacturing Engineering is required. Master’s Degree is preferred.
SpineCraft offers a generous compensation and benefits package that includes comprehensive medical and dental insurance benefits plus a 401K retirement plan. Salary is competitive and commensurate with experience.
Interested candidates may email their resumes to careers@spinecraft.com with a copy to hr@spinecraft.com
Quality Control Inspector - Medical Devices
About the Job:
SpineCraft develops and manufactures spine surgery implants & instruments systems that provide comprehensive spine care solutions to improve and enhance quality of life for patients with back pain, neck pain, degenerative disc conditions, spine deformities and injuries due to trauma.
Job Description:
The Quality Control Inspector will be responsible for inspection of finished spine surgery implants & instruments for conformance to specifications and quality standards in a team environment and will work on diverse assignments following established standard procedures.
Responsibilities:
The candidate should possess at least an Associate degree or equivalent and 2-3 years Quality Inspection in a medical device manufacturing environment, and must possess the required competencies and skills.
SpineCraft offers a generous compensation and benefits package that includes comprehensive medical and dental insurance benefits plus a 401K retirement plan.
About the Job:
SpineCraft develops and manufactures spine surgery implants & instruments systems that provide comprehensive spine care solutions to improve and enhance quality of life for patients with back pain, neck pain, degenerative disc conditions, spine deformities and injuries due to trauma.
Job Description:
The Quality Control Inspector will be responsible for inspection of finished spine surgery implants & instruments for conformance to specifications and quality standards in a team environment and will work on diverse assignments following established standard procedures.
Responsibilities:
- Perform visual, dimensional, and functional inspections of product based on documented company specifications (i.e. drawing, procedure, work instructions, etc.).
- Review and maintain all inspection documentation.
- Review device history records for product lot releases.
- Prepare graphs or charts of data or enter data into computer for analysis.
- Fill out and process quality reports.
- Participate in the corrective/preventive action program, as required.
- Must be able to read complex mechanical blueprints to complete incoming and final inspections.
- Must have extensive knowledge using different measurement equipment to assure that devices are manufactured and functioning according to specification.
- Must be able to accurately document and maintain and up-to-date acceptance and rejection records.
- Must be able to work within the guidelines of the Quality Policy, Quality Directives, ISO 13485 Standard, and applicable Regulatory Requirements (i.e. FDA 21 CFR PART 820).
- Maintains appropriate knowledge to efficiently perform all assigned work and utilizes this knowledge base to become proficient on new and unfamiliar assignments.
- Must be able to maintain an organized work area.
- Must Demonstrate computer proficiency and possess a good level of Microsoft office skills.
- Excellent English written and verbal communication skills required.
- Excellent math skills required.
The candidate should possess at least an Associate degree or equivalent and 2-3 years Quality Inspection in a medical device manufacturing environment, and must possess the required competencies and skills.
SpineCraft offers a generous compensation and benefits package that includes comprehensive medical and dental insurance benefits plus a 401K retirement plan.
Interested candidates may email their resumes to careers@spinecraft.com with a copy to hr@spinecraft.com
