This role is responsible for testing products, and recording and analyzing results data for incoming raw materials, returned goods, during product development, and manufacturing.
Essential Responsibilities: (other duties as assigned)
Inspect incoming product to verify quality requirements are met
Design, install, and evaluate quality assurance process sampling systems, procedures, and statistical techniques
Design or specify inspection and testing mechanisms and equipment
Receive, log and process RMAs. Begin the investigation of customer complaints regarding quality and product shipped.
Manage Material Review Board (MRB) team meetings to ensure non-conformances are driven to completion, including investigation and material handling
Control nonconforming material area, maintain inventory accuracy and disposition product on a timely basis
Audit work cells to quality system requirements
Manage calibration and shelf life programs
Test, calibrate, maintain and repair electrical, mechanical, analytical and electronic devices for conformance
Use metrology equipment such as caliper, micrometer, height gauge, CMM, etc.
Serve as a resource for production floor personnel
Update quality metrics as assigned
Support ongoing improvements in customer feedback, inventory accuracy, inspection responsiveness and returns processing
Help formulate specifications, quality assurance policies, and procedures.
May conduct training on quality assurance concepts and tools.
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
Competencies:
Time Management (high degree of self-motivation and organization)
Accountability
Critical thinking and problem solving - the ability to understand the Big Picture
Decisiveness (willingness to exercise ongoing prudent judgment with due care and precision)
Compliance (attention to detail and accuracy, ethics)
Quality and Safety Focus
Attention to Detail/Quality of Work
Teamwork / Team player
Responsibility
Communication
Results orientation
Demonstrate Brewer’s core values of Learning, Innovation, Integrity and Collaboration
Physical / Mental Demands:
Medium work. May be required to lift up to 40lbs on a regular basis and occasionally 50+lbs.
The worker is required to have visual acuity to determine the accuracy, neatness, and thoroughness of the work assigned or to make general observations of facilities or structures.
The worker is required to have the physical dexterity and ability to move in the following manner; stooping, crouching, reaching, standing, walking, pushing, pulling, lifting, grasping, talking, repetitive motion
The worker is not substantially exposed to adverse environmental conditions.
The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.
Working Environment:
Manufacturing Floor
Qualifications:
Minimum 3-5 years quality experience
Previous experience in a medical device company managed to ISO 13485 and/or 21 CFR 820
Self-motivated and able to exercise good judgment on allocation of time spent between patrol, audit, sampling, and testing functions of job.
Ability to work independently in a fast-paced environment
Ability to read/understand product drawings and inspection plans
Must be able to read and interpret written specifications and maintain documentation required internally and by the customer.
Must have the ability to perform and understand product testing procedures and test equipment.
Knowledge of Microsoft Office including Excel, Word and Outlook
Minitab and ERP systems experience desired
Specialized advanced courses in the quality field desired
HELPING HEALERS HEAL!
At Brewer we design medical and dental products with comfort, ergonomics, efficiency and value in mind. Brewer has been in business for over 75 years, and we continue to be strong force in the medical and dental industries due to quality we strive for.
1. Stability –We celebrated our 75th anniversary in 2022 and continue to grow year over year.
2. Helping Healers Heal –We are in the medical industry and take great pride in assembling products that promote the health and safety of both patients and medical practitioners.
3. Benefits Above Benchmark – we subsidize 80% of the premiums on our medical plan for employees. Brewer pays 100% of premiums for each full-time employee’s group term life insurance and both short-term and long-term disability benefits.
4. Culture – you are at work as much as you are at home, so it is essential to enjoy the people around you. Our values are Learning, Integrity, Innovation, and Collaboration and we focus on candidates that demonstrate these values. We encourage our employees to grow in their roles and take great pride when they step out of their comfort zone and raise their hand to something new.
5. Work Hard Play Har...d Environment – Our customers always come first so we make sure the work gets done, but we also like to have some fun along the way! Examples: Annual Kickball/Cookout, holiday party, charity fundraisers, March Dart Madness tournament and that is just the beginning!