SpineCraft develops and manufactures spine surgery implant & instrument 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 trauma.
We are looking for a Quality Control Inspector to join our growing team.
Qualifications and Experience Requirements:
- Associate degree or equivalent and 3-5 years Quality Inspection in a regulated industry (medical device or pharmaceutical preferred).
- Must be able to read complex mechanical blueprints to complete incoming and final inspections.
- Must have good 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.
- Good math skills required.
- Perform visual, dimensional, and functional inspections of received product based on documented company specifications (i.e. drawing, procedure, work instructions, etc.).
- Perform receiving inspection for sterile and non-sterile products based on pre-determined acceptance criteria.
- Perform Inspection of returned loaner and consignment kits based on documented company specifications
- Review and maintain all inspection documentation.
- Assist in reporting and documenting vendors’ non-conformances.
- Assist in the review of device history records.
- Assist in maintaining calibration schedule and ensuring that all measuring equipment are calibrated, suitable for use and records are well documented.
- Enter data into computer for analysis and for evaluating vendors’ performance.
- Participate in the corrective/preventive action program, as required.
- Other special projects/duties as assigned in support of quality department and other business needs.
SpineCraft offers a generous compensation and benefits package that includes comprehensive medical and dental insurance benefits plus 401K retirement plan.
SpineCraft is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, sexual orientation or any characteristic protected under applicable law.