Sr. Quality Engineering Program Manager (Toronto)

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?

The Senior Quality Engineering Program Manager is responsible for the Design Assurance and Product Compliance function at the Lewisville, TX site.

This position will lead the QE team in providing technical support to ensure compliance with Orthofix Quality Standards, FDA, and applicable OUS regulations as well as assure product quality and safety.

The Quality Engineering Manager will support and drive improvements across the entire lifecycle of products, including new product design controls, manufacturing process design, equipment qualifications, design and process verification, and validation inspection plan development, and change control.

In addition, the Quality Engineering Manager partners closely with other functions to ensure all decisions and actions are determined through the application of good science, risk management, and the most current regulatory expectations.

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.

Represent Quality Assurance in all aspects of the company's design and development of new medical device products.Participate as the Quality Representative in PERT (Product Experience Review Team) and Risk Management activities.

Investigate failures and defects resulting from manufacturing supplier, and other sources to identify root causes and implement corrective actions.

Establish inspection certification program for IQA Inspectors and Production Assemblers.Review and approve other GMP documents including, but not limited to, manufacturing validation protocols and reports, annual validation reviews as well as sterilization and transit studies.

Provide oversight for processing change control requests and nonconforming product dispositions.Actively participate in continuous improvement activities with cross-functional teams.

Maintain the product as state-of-the-art through review of updated standards and regulations.Support complaint investigations and post-market activities to satisfy regulatory requirements and internal Quality objectives.

Interface with Regulatory Affairs to support regulatory submissions as necessary.Manage product development programs, working closely with Project Managers, Product Owners, Software Development and Test Team, Tools Team, Quality and Regulatory to develop project priorities, milestones, and schedules.

Track program progress against targets.Work with stakeholders to set product development priorities.Plan product development and releases.

Assess and manage program risks. Build mitigation plans as needed.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 equivalentExperience, Skills, Knowledge and / or Abilities : At least 10 years of related experience.

Knowledge of domestic and international medical device quality system laws, regulations, and standards, such as 21CFR Part 820, ISO 13485 : 2016, ISO 14971, and ISO 11135.

Able to interpret medical device law into workable, efficient, and effective practices and procedures.Personnel Management.

Experience with ERP systems, electronic document, and record management systems.Knowledge of configuration management.Able to lead and make independent decisions.

Excellent communication skills.Able to adjust priorities as required by the needs of internal customers.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 : N / AAdditional Experience, Skills, Knowledge and / or Abilities : N / APHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONSThe 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, 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.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.