What are the responsibilities and job description for the Senior Manager, Quality Systems position at Orthofix?
Why Orthofix?
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'll make a difference?
As the Senior Quality Systems Engineer you will be responsible for coordinating all of the quality system related activities within the Quality department in support of the Quality mission to improve the quality of products through focused process improvement. In this position you must ensure QS compliance with company quality system requirements as well as applicable standards and regulations. The Senior Quality Systems Engineer will report to the Quality System Supervisor.
What will your duties and responsibilities be?
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
- Support the maintenance and continuous improvement of the local Quality Management System processes.
- Support the implementation of Orthofix Global Quality System processes, including but not limited to CAPA, complaint handling, audit, and training.
- Prepare reports by collecting , analyzing, and summarizing data regarding quality processes/product capabilities, problems and trends, and quality related design & development topics
- Lead the Corrective Action/Preventive Action process. Promote effective and timely resolution to quality problems with the focus on true root cause and verified corrective action.
- Provide support and participate in the validation activities for Quality System software applications.
- Lead the Internal Audit Process. Schedule and perform audit activities, to include pre-audit planning, audit execution and evaluation, and post-audit follow-up and recommendations.
- Participate in external audits with ISO Registrar, Authorized Representative, and other government agencies.
- Review and recommend improvements to the implemented Quality Management System (Quality Manual, Standard Operating Procedures and Work Instructions).
- Collect process metrics and lessons learned, review and evaluate processes, and work products, and recommend improvements as appropriate.
- Ensure that all applicable external standards, both systemic and product specific, are up to date, available for use, and properly implemented.
- Review documents on ECOs to ensure that the Quality System remains in compliance with all applicable laws and standards, and that the system is as efficient and effective, as possible.
What skills and experience do you need?
- Bachelor's degree in engineering and 7 years related quality systems experience.
- Excellent technical writing skill and ability to communicate well (both written and verbal) laterally and vertically.
- Computer knowledge: MS Word; MS Excel, MS Project, Visio, and Outlook.
- Logical cognitive skills and ability to apply scientific methods and/or systems thinking.
- Able to identify variables affecting all aspects of quality.
- Able to meet deadlines and/or objectives as directed.
- Must be able to interpret device law into workable, efficient and effective practices and procedures.
- Lead auditor certification highly desired.
What skills and experience would be helpful?
- Knowledge of internet investigation for new and updated standards.
- Experience with global audits such as with Brazil and Japan.
- Systems engineering a strong plus.
- An aptitude for Quality and Regulatory Compliance.
- Experience in the spine and/or orthopedic industry.
What will the physical demands and work conditions be like?
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Regularly required to sit for extended periods of time; frequently required to stand, walk and use business equipment daily such as P.C., copier, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects of up to 40 lbs.
- Eyesight and hearing must be correctable to standard level.
- Travel required 10%, therefore must be able to utilize airplane, taxi and car.
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.
Orthofix complies with all applicable federal, state, and local laws regarding equal employment opportunities (EEO) to all employees and applicants for employment. Orthofix makes its employment decisions without regard to race, color, religion, sex, national origin, age, disability, genetic information, or any other status protected by law. In addition to federal law requirements, Orthofix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has employees. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
