Inspection Supervisor

Why Orthofix?

Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech.

Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further.

How you'll make a difference?

Ensures the Orthofix QCRI team is in compliance with domestic and international laws, standards, regulations, Orthofix quality system requirements, and corporate objectives; primarily through inspection and control of raw materials, first article, in-process and finished goods, performing product testing; recording and assessing quality data; providing work direction to staff, training, assisting in corrective and preventive actions, compiling and reporting quality data in support of management review and other operations quality compliance and improvement initiatives.

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 and tasks as needed and assigned.

• Quality System: Accomplishes quality and organization mission by completing related results as needed.
• Supervising – the QCRI Inspection staff as it relates to all areas of inspection & workmanship. This includes all day to day activities and defining priorities, managing times, etc.
• Quality Control:
• Accomplishes quality work requirements by orienting, training, assigning, scheduling, and coaching employees in the areas of nonconforming material, Inspections and test, Acceptance Activities.
• Meets work standards by following production, productivity, quality, and customer-service standards; resolving operational problems; identifying work process improvements.
• Develops procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
• Develops Quality metrics and reports/supports the reporting of manufacturing yields, supplier performance, customer complaints, nonconforming material, and other quality costs.
• Meets quality cost standards by monitoring expenses; implementing cost-saving actions.
• Approves incoming raw materials, first article, in-process and finished materials through inspectors who must adherence to specifications, conduct of visual and measurement tests, materials rejection, communication of required adjustments to production supervisors, return of products for re-work, and confirmation of re-work as necessary.
• Keeps measurement equipment operating by enforcing adherence to operating instructions; calling for repairs.
• Maintains safe and healthy work environment by following and enforcing standards and procedures; complying with legal regulations.
• Updates job knowledge by participating in educational opportunities; reading technical publications
• CAPA / SCAR: support Sustaining Quality or Supply Chain with DHR data as needed
• Training: Training employees on requirements for internal procedures, work instructions including (GDP / GMP requirements), and applicable regulations.
• Quality Reporting: tracking; compiling; and reporting quality metrics (key process indicators) related to responsibilities and effectiveness of the Operations Quality department.
• Continuous Improvement: root cause analysis, problem solving, continuous improvement and related corrective and preventive action as they relate to overall effectiveness of the quality control department and as appropriate based on other quality data.
• Third-Party Quality System- and Product-Related Audit Support: support for third-party audits conducted by FDA, Notified Body, and others and coordinating related corrective action activities
  
  
  

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 or equivalent
  
  
  

Experience, Skills, Knowledge And/or Abilities:

• 5 years related work experience in regulated industry
• Knowledge of domestic and international medical device quality system laws, regulations and standards
• 3 years experience in a leadership role
• Experience with ERP systems, electronic document and record management systems and ability to develop process workflows
• Attention to detail: work must be accurate and complete
• Ability to lead by example and make independent decisions
• Excellent communication skills
• Works well in a Team environment
• Adaptable
• Computer knowledge: MS Word; MS Excel, MS Project, etc.
• Regular attendance required.
  
  
  

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/A
  
  
  

Additional Experience, Skills, Knowledge And/or Abilities:

• Ability to effectively perform research, including navigating the Internet
• Quality Certifications (CQA, CQE, Lead Assessor, etc.) or willingness to get certified
• Formal training in quality system and medical device requirements for the US, Canada, and EU
• Knowledge of Oracle a plus
• Knowledge of Agile a plus
  
  
  

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.

• No additional physical requirements or essential functions for this position.
  
  
  

The anticipated salary for this position for an employee who is located in California is $85,000.00 to $124,800.00 per year, plus bonus, based on performance, 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. The Company is a multi-state employer and this pay scale may not reflect the pay scale 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.