Job Details

Description

We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginning!

Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At SeaSpine and Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun!

How you will make a difference:

Assures quality requirements are in compliance with FDA, ISO, EN, AATB, Canada and other national and international standards, as applicable. Provide QA technical support to operational areas (i.e. Manufacturing and Product Development) and Quality Assurance in order to ensure product quality and safety. Support/Coordinate the CAPA and Complaint program, as required. Interface with other departments to assure quality requirement are met.  Conduct internal and external audits.  Develop and execute product, process, and test method validations.

Your key responsibilities:

Perform standard engineering assignments which are typically a significant portion of a larger project.  Select sound techniques to solve problems and make design recommendations under direction of supervisor.  Assess results for application, validity and conformance to specifications.  Recommend material and process specifications.

• Use quality engineering tools to for problem solving (e.g. FMEA, SPC, DOE).
• Analyzes complex production and quality trend data to identify and solve problems.
• Support Risk Management activities for the HHE, Complaint and CAPA process.
• Support for design controls
• Preside as a key quality participant in compliance audits and FDA inquiries.
• Support post market activities such as complaint investigations, complaint trending, CAPA and FCA.
• Lead small project teams as needed to accomplish project objectives.
• Perform equipment, product, and process qualifications/validations.
• Implement changes to products and manufacturing to improve quality and reliability and to address improvement of process, design, or materials.
• Provide QA technical support in order to ensure compliance with FDA, ISO, EN, AATB, and other national and international standards, to assure product quality and safety.
• Provide QA investigational support for product NCRs, CAPAs and Complaints
• Conduct risk management/risk assessment activities.
• Participate in New Product Initiatives to ensure smooth transitions to production.
• Manage and conduct both internal and external audits and qualify new suppliers and/or components.
• Interface with Suppliers to review specifications, address supplier corrective actions and resolution of quality programs.
• Works with the Calibration department on development of gauging, review and approve calibrations to requirements and conduct Out of Tolerance investigations.
• Support the Quality Management System (e.g., facilitate change orders, CAPAs, Document Control, and Design Control System).

Who you are:

• Bachelor’s Degree in Engineering or Biological science
• Minimum 5 years of related experience with exposure to medical device products
• ASQ C.Q.E. and/or C.Q.A., Lean, Six Sigma, Process Excellence – preferred 
• A combination of advanced degree & related work experience may be considered
• Mastered regulatory compliance awareness, including at a minimum 21 CFR 820, 21 CFR Part 11, ISO 13485, ISO 14971, MDD. Knowledge of 21 CFR 1271 preferred
• Excellent communication skills, both verbally and in writing
• Ability to interact with all levels of personnel throughout the organization
• Must have the ability to multi-task in fast paced environment
• Must have strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of moderate scope and complexity
• Must have technical and organizational skills
• Demonstrate experience and understanding in use of statistical tools

The anticipated salary for this position is $113,326 to $124,232 per year, plus bonus and benefits. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type and years of experience within the industry, education, etc.

We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.

 This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.