Quality Specialist

Great opportunity to join the Quality Team at a dynamic and growing company. The business manufactures, markets and sells medical devices to Spine, Orthopedic, Medical Aesthetic and Medical Wellness practices. As a Quality Specialist you are critical to the business and will be responsible foroverview of documentation, process management and successful closure for product transactions, including product component inspections, incoming new product inspection, product returns and distributed product management and any products cycling back from the field. Creation and review of all related documentation and labeling is required as part of this function.  This role works closely with Operations, Service, R&D, Manufacturing, Finance and Customer Service. 

Duties and Responsibilities:

• Inspection and quality tests on incoming products.

• Review of release documentation.

• Completion, filing and maintenance of device history and training records.

• Work with Quality team and management to establish and document appropriate inspection methods.

• Support and participate in process improvements and perform quality process checks.

• Handling activities related to Customer complaints from open to closure to include investigations and mandatory medical device reporting against company policies and regulatory guidelines.

• Guiding Supplier and Equipment management against company policies and procedures.

• Prepare and implement quality assurance policies and procedures.

• Ensure that standards and safety regulations are observed and followed. 

Knowledge, Skills and Abilities:

Required: 

• Bachelor’s or Associate Degree in science or business or equivalent work experience.

• Exceptional attention to detail and organizational skills.

• Open communicator willing to present issues along with solutions.

• Ability to manage an organized workload and prioritize demands.

• Ability to juggle multiple responsibilities simultaneously, stay focused on deadlines and handle complex projects efficiently and have a positive mindset.

Preferred 

• Experience with quality inspection or document control in healthcare, medical devices or otherregulated environments. 

• Experience in engineering, science related industry.

• Quality Management Systems (QMS) experience.

• Understanding of document control process and procedures in accordance with ISO 13485:2016, 21 CFR 820 FDA Quality System Regulations (QSR) and EU Regulations (MDR).

• Computer software knowledge (i.e., Word, Excel, PowerPoint). 

• Experience with product labeling software such as BarTender and other inventory systems such as Q-Stock is a plus.

• Knowledge of geometric tolerancing and ability to interpret and apply inspection requirements.

• Six sigma certification.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee tosuccessfully perform the essential functions of this position.

Hours:

Full time, 40 hours per week with potential work hours in addition to 8am -5pm in the instance of audits and other scheduled activities related to the business Quality Management System. 

Physical Demands:

While performing the duties of this position, the employee is regularly required to talk or hear. Theemployee frequently is required to use hands or finger, handle, or feel objects, tools or controls. Theemployee is required to stand; walk; sit; reach with hands and arms and pull/push; climb or balance; andstoop, kneel, crouch, or crawl. The employee must lift and/or move up to 50 pounds without assistance.

Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, and the ability to adjust focus.

Work Environment – Office Based

This job operates in a professional office environment with minimal exposure to dust, chemicals ornoise. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Compensation:

• Competitive salary 

• Comprehensive benefits 

• Paid time off and holiday policies