Validation EngineerOrchid Orthopedic Solutions - Memphis, TN
: Memphis TN
SUMMARY OF POSITION
Working for a leading manufacturer of medical devices and registered with the FDA. The candidate who obtains this position will execute improvement activities; research, write, and execute validation protocols/activities for special processes and equipment for medical devices, assess validation impact for manufactured products at our facility pursuant to the appropriate Regulatory (FDA), customer requirement(s), and Self Certification documentation activities.
Develops validation protocols, performs testing, and writes validation reports for various equipment manufacturing processes and products.
Responsibilities include:o Analysis of data, generation of reports and memos concerning above projects.
Provide recommendations based upon data.Determination of process capability of new equipment through execution of approved protocols and assures defined parameters are incorporated into respective operating procedures and other records.
Adheres to all company and cGMP procedures.
Participates in and provides input to new product / process team meetings.
Ensure current, relevant standards are adhered to for all processes.
Analyze data with Minitab
Use statistical rationale to determine process capability, sample size, high/low process parameters, and gage R&R activities.
Maintains a safe and healthy work environment by following standards and procedures; complies with legal and ethical requirements.
Performs other related duties and tasks as required.
Perform other duties as required or directed by the Department Supervisor or Lead.
EDUCATION AND EXPERIENCE
Bachelor’s degree in biomedical, industrial or mechanical engineering field preferred
OR equivalent in years of experience and minimum of three to five years’ engineering and manufacturing experience, preferably in medical devices.
Should possess experience in validation of new and existing processes and equipment.
Should possess experience and knowledge of orthopedic implants and/or other medical devices.
Experience with Microsoft software products Excel, Word, Outlook, and PowerPoint is required.
Experience with Sterilization, Packaging, and Labeling preferred.
Experience in project leadership is preferred.
Experience participating in customer, vendor, and/or internal audits is a plus.
SKILLS & ABILITIES REQUIRED
3 years test / validation experience preferred
Statistical Analysis experience using Minitab (excellent analytical skills)
Medical device experience – highly preferred
Excellent written and oral skills
Must be proficient in interfacing within all levels of the organization
Must support Quality Assurance and Lean Manufacturing initiatives within the facility
Must be able to lead a small, technical team through validation exercises from protocol generation and execution through presentation to customers for approval.
Must be able to coach the organization in validation standards and be current on industry trends
Must be able to work in a fast paced environment with changing priorities.
14 days 10 hours ago
Orchid Orthopedic Solutions
Please review all application instructions before applying.
From our employees, to our customers, to the surgeons performing surgery and ultimately, to the patients that receive care using the products we make, we strive to affect people’s lives in a positive manner. We feel fortunate to be working in an industry that has the ability to impact lives in such a profound way and we are proud of the services we provide.
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