Quality Technician - Complaints (Oklahoma City, OKC)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

The Complaint Investigation Technician will perform complaint investigations utilizing physical product evaluation methods, material characterization testing, documentation evaluation and simulated use testing in order to establish a probable root cause and failure mode associated with a reported complaint event.

This position will document the results of the evaluation in the designated complaint management system utilizing good documentation practices and work directly with quality engineering and management to establish when containment and corrective actions might be necessary to mitigate future recurrence.

What will you be doing?

The complaint investigator will ensure compliance with all appropriate laws and regulations, relevant to the job function.

• Perform complaint investigations utilizing physical product evaluation methods, material characterization testing, documentation evaluation and simulated use testing to establish a probable root cause and failure mode associated with a reported complaint event.

• Maintain the organization and cleanliness of the laboratory facility and test equipment.

• Perform material movements physically and electronically. Coordinate the transfer activities of OEM devices back to the OEM for evaluation by procuring RA's, PO's, Service Note records and packaging of the products as well as manage communications with the OEM regarding the investigation requirements for the complaint event.

• Participate in group meetings to disseminate new failure modes and root causes associated with complaint events to applicable stakeholders such as research and development, manufacturing, and quality engineering.

• Other duties may include performing clerical duties associated with the transcription of complaint information from various sources into the designated complaint database, ordering of lab supplies, and coordinating calibration and preventive maintenance of lab equipment.

What will you need to be successful?

• Education:

  • High School Diploma or equivalent required.

  • A.A or A.S degree preferred.

• Experience:

  • Minimum of 4 years work experience in a regulatory industry

  • Experience in medical device industry preferred

• Understanding of basic inspection techniques and problem-solving skills needed. Experience working in FDA, GMP and ISO environment preferred

• Experience using computer systems and software including Agile, SAP and Microsoft Office Suite highly desirable

• Must be fluent in English language

• Ability to work effectively with a diverse network of internal and external departments and/or individuals

• Good interpersonal & communication skills, both written and verbal.

• Ability to prioritize daily work tasks

• Knows and adheres to the quality policy of the company and the quality related procedures and instructions

• Reports any deviation in product or process, of which they become aware to the respective manager or Quality department

• Completes all necessary training in the area of Quality and GMP (Good Manufacturing Practice)

• Immediately reports any dissatisfaction or complaint which is brough to their attention from a customer or patient regarding a Smith & Nephew product (e.g., in terms of quality, durability, reliability, safety or performance) to the complaints department

• Complies with all health, safety and environmental policies, procedures, and job hazard analyses applicable to specified job actives; including medical evaluations as required by job functions

• Competes all required HSE training

• Physical Demands:

• Weight Lifting: Medium (5.1kg -30Kg)

• Position: Mostly sitting

• Repetitive Motion: Mostly computer use with some motions < 10 moves/30 seconds.

• Chemical Exposure: Cleaning use only

• Physical Risk (Personal Protective Equipment - PPE): Occasional use of PPE required when handling contaminated or potentially contaminated devices.

You. Unlimited

We believe in creating thegreatest good for society. Our strongest investmentsare in our people and thepatients we serve.

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

Other reasons why you will love it here!

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
  Work/Life Balance: PTO, Paid Holidays, Flex Holidays, Paid Community Service Day

• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more!

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.