Senior Manager, Quality Compliance

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?

This Senior Manager, Quality Compliance is responsible for developing, defining, educating, advocating, and managing a superior compliance culture throughout the company. Likewise, this role must ensure QS compliance with company quality system requirements as well as applicable standards and regulations. The Senior Manager, Quality Compliance is also responsible for ensuring the company's management and employees are in compliance with the rules and regulations of regulatory agencies and that company policies and standard operating procedures are being followed.

What will your duties and responsibilities be?

The following are the essential functions of this position. This position may be responsible for performing additional duties as tasks as needed and assigned.

• Ensures appropriate quality management system requirements have been effectively established and implemented to maintain compliance with US FDA's Quality System Regulation, the European Medical Device Directive / Regulation, ISO13485, American Association of Tissue Banks (AATB), and other relevant domestic and/or international regulatory requirements

• Executes Gap Analysis and/or Risk Assessments to ensure evaluation of key areas, such as manufacturing operations, laboratory and maintenance and engineering, are in compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, etc.

• Monitors completion of Post-Market activities, including complaint handling, adverse event reporting, Health Hazard Evaluations (HHE), and Post Market Surveillance to verify satisfaction of regulatory requirements, and manages or supports Recalls and Field Removals

• Maintains awareness of regulatory landscape and takes appropriate steps to ensure continued QMS compliance

• Ensures the Quality Policy and Manual have been effectively established, communicated, and implemented to maintain compliance with domestic and/or international regulatory requirements

• Maintains CAPA process and verifies CAPA's are implemented as required to maintain suitability of both products and the Quality System

• May provide training and/or training presentation documentation pertaining to FDA inspections, e.g. FDA hot topics, interaction with FDA officials, new regulatory approaches to inspections, etc.

• Ensures Quality Management System audits are planned, performed, results reported to executive management, and necessary / required corrective and/or preventive actions are taken in accordance with established procedures

• Monitor risk management process, including post-production risk, to ensure all regulatory and compliance obligations are satisfied

What skills and experience will you need?

The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.

Education/Certifications:

• Bachelor's degree in engineering or equivalent combination of education, training and experience

Experience, Skills, Knowledge and/or Abilities:

• 10 years' experience in medical device industry and quality systems, quality auditing, and/or regulatory compliance experience

• 4 years' Management experience

• Knowledge of domestic and international medical device quality system laws, regulations, and standards, such as 21CFR Part 803/806/820, 21CFR Part 1271, ISO 13485:2016, ISO 14971

• Excellent technical writing skill and ability to communicate well (both written and verbal) laterally and vertically

• Project planning and management capability a must

• Computer knowledge: MS Word; MS Excel, MS Project, Visio, outlook, access, etc.

• Logical cognitive skills and ability to apply scientific methods and/or systems thinking

• Ability to identify variables affecting all aspects of quality

• Ability to meet deadlines and/or objectives as directed

• Must be able to interpret device law into workable, efficient, and effective practices and procedures

What qualifications are preferred?

The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.

Education/Certifications:

• Bachelor's degree in engineering

Additional Experience, Skills, Knowledge and/or Abilities:

• Knowledge of internet investigation for new and updated standards

• Experience with global audits such as with Brazil and Japan

• Current with domestic regulatory thinking

• Experience in the spine and/or orthopedic industry

• Experience with medical device reporting and complaint management a strong plus

• Knowledge of statistical techniques

• Lead auditor certification highly desired

PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.

• 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

The anticipated salary for this position for an employeewho is located in Californiais$XXto$XXper year, plus bonus, based on performance, equity, and benefits. The finalpayoffered 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. The Company is a multi-state employer and thispayscale may not reflect thepayscale for an employee who works in other states or locations.

DISCLAIMER

The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee's at-will employment status.

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.