Orchid Orthopedic Solutions Supervisor, Quality Compliance in Chelsea, Michigan
SUMMARY OF POSITION
Responsible for the effective operation of the regulatory compliance organization including complaint handling, corrective and preventive action, internal “process” auditing, customer audits, document control, ISO certification and quality system training.
- Responsible for planning, organizing, and directing all regulatory compliance activities.
- Oversee product complaint investigation and resolution. Ensures complete and timely analysis and reporting of all customer and internal complaints.
- Oversees the corrective and preventive action (CAPA) system and ensures complete and timely and adequate action is taken using scientific problem solving methods.
- Assures compliance with all internal and external requirements and regulations through the maintenance and improvement of the quality management system.
- Interfaces with Quality and Regulatory personnel throughout the corporation.
- Directs internal and external audits of the quality system and is responsible for all follow-up activities including complete and timely responses.
- Provides quality system training to all new employees and conducts ongoing refresher training for existing employees.
- Assists with the implementation of continuous improvement activities throughout the organization.
- Develops and issues status reports to monitor the effectiveness of the QMS.
- Stays abreast of existing and changing regulations, including FDA QSR, ISO 9001, and ISO 13485.
- Ensure nonconforming product returns (customer returns and loaner returns) are processed daily.
- Support Quality staff with activities related to quality issue verification, Product Hold Orders, product quarantine and product complaint evaluation, as required.
- Establishes/manages quality reporting process to ensure system is functioning effectively.
- Oversees document control activities.
- Manages personnel operating within areas aforementioned.
EDUCATION AND EXPERIENCE
- Bachelor degree in quality management, engineering, business administration, or equivalent.
- Five or more years of relevant quality system experience in a highly regulated industry such as medical devices, aerospace, automobile or nuclear.
- Experience with ISO/CE certification process and experience with US and relevant international medical device regulations.
- ASQ Quality certification preferred (e.g., CQE, CQA, CQM, etc.).
SKILLS & ABILITIES REQUIRED
- Alignment to Orchid’s core values
- Strong communication, leadership and organization skills with the ability to prioritize and meet deadlines for multiple projects
- Good technical and project management skills
- Ability to make decisions and work independently
- Problem solving ability
- Strong interpersonal skills
- Good analytical and problem solving skills
- Proficient using Microsoft Office programs
- Ability to interact with all levels of employees
- Ability to discern and appropriately communicate sensitive issues
- Must be able to remain in a stationary position for prolonged periods of computer based writing
- Use of Personal Protective Equipment (PPE) as determined for the position.
- Occasional travel
- Must submit to and pass background and substance abuse tests.
- Must be able to provide proof of eligibility to work in the United States through eVerify.
- Must adhere to the Company Code of Conduct and Core Values.
- Must follow designated safety rules and regulations.
- Must be able to fulfill all the requirements of this position, including requirements related to the company’s Safety, Quality and Environmental Management System Policies and procedures. If you are interested in applying for this position, please send your resume to: email@example.com
Location: Chelsea MI