Quality Analyst

Avalign Technologies is the premier, full-service supplier of surgical implants, instruments, and delivery systems. Expertise in engineering, diverse manufacturing capabilities and dedication to clients’ needs ensures our customers’ success from start to finish. Avalign Technologies brings the highest quality standard and custom products to our OEM customers across multiple surgical specialties. The Avalign leaders are passionate about forging the strongest network of medical product manufacturers – this passion provides increased speed to market, maximizes our customers’ revenue and delivers solutions at the lowest total system cost.

Job Title:                                       Quality Analyst I

Department:                                  Quality Assurance

Reports To:                                   Quality Manager

Summary:  The Quality Analyst will maintain quality assurance programs.  This role will also ensure that Quality System elements are driving continuous improvement.  Responsible for inspecting received material, work-in-progress and finished products to ensure conformance with work order specifications, diagrammatic and template specifications as outlined below. This will be a second shift position from 10am to 7pm.

Essential Duties and Responsibilities include the following. 

• Performs basic statistical analysis and communicates results to teams.
• Assists in failure analysis, investigation and CAPA activities.
• Coordinates new product additions. 
• Performs data collection; populates and updates database; logs and tracks issues/actions.
• Conducts or guides testing and data analysis which demonstrate that product/processes meet acceptance criteria.
• Supports efforts to align site initiatives with overall company initiatives while ensuring compliance to regulatory standards.
• Assure site training requirements are met and assists in establishment/execution of training as needed.
• Performs in-process and final quality inspection of finished products in accordance with established
• procedures.
•  Completes inspection records and checklists and documents all instances of rejected product or material problems in a daily production report.
• Documents appropriate information for quality inspection for each order; reports nonconformance of products and processes and reports any unusual discrepancies or problems promptly to supervisor or manager.
• Adheres to established company policies and procedures paying special attention to safety regulations.
• Wear personal protective equipment in accordance with safety and training guidelines.
• Helps train new employees as required.
• Other related duties as assigned or required.

Qualifications:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skills and/or abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Excellent written and verbal communication skills

• Background in customer service and/or quality assurance desired
• Excellent time-management, documentation, and organizational skills
• Exceptional computer skills
• Highly organized and detail-oriented
• Team-oriented and motivated
• Strong work ethic and dependable
• Professional Appearance
• Medical device experience a plus but not required

Education and Experience:  

• Bachelor's Degree (B.A./B.S.) from four-year college or university; degreed candidates in Life Sciences are preferred or a minimum of 2 years of relevant quality experience and experience with medical device industry is considered a plus

• FDA/ISO knowledge and experience preferred

What You Won’t Do:

• Feel stuck – we offer great opportunities to advance and learn
• Get bored – we make a high variety of products, so no day is the same
• Feel like a number – we’re a close-knit bunch and always have each other’s backs 

Who You Are:

• A self-starter who thrives in a fast-paced environment
• A quick learner who is always ready to gain depth of knowledge in manufacturing processes
• A reliable individual who knows the importance of showing up when it counts
• Someone who accept assignments with an open, cooperative, positive and team-oriented approach
• Someone who is able to plan and execute plans across teams
• An effective communicator, both written and verbal

What You’ll Enjoy:

• Competitive compensation and benefits package
• Comprehensive medical, dental, and vision insurance
• Paid vacation and 10 observed paid holidays per year
• Employer funded Basic Life and AD&D insurance
• Employer funded STD and LTD insurance
• Tuition reimbursement
• Great 401(k) with company match
• Generous employee referral bonus program
• Working for a thriving, performance-based company that values promoting from within and career advancement
• Temperature controlled environment
• Community involvement investing and giving back to the community
• Additional free resources such as travel assistance, EAP, etc.

Avalign conducts a comprehensive background, drug testing, highest level of education completion verification, and reference checks.
 

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status. We are an employer that participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.