QA Associate - Weekend

Job Details

Experienced

Legal Address - Longmont, CO

Job Posting Date(s)

04/15/2025

Description

Quality Assurance Associate – Weekend Shift

The quality specialist will play a critical role in ensuring compliance with ISO and FDA regulations in our Class II/Class III medical device development and manufacturing processes.

Organizational Competencies & Cultural Values:

The mission of every employee at Osypka Medtec is to serve, support, and improve the lives of our patients and customers by adding value through innovative quality medical devices and services.

Our vision is to be a leading medical company in the development, production, sale, and marketing of permanent and temporary devices and services around the world.

All employees are expected to provide customer service, communicate in an effective manner both verbally and in writing, display professionalism and integrity, as well as work efficiently, effectively and accurately. Employees should take the initiative, solve problems, display good judgment, and take ownership for delivering a high-quality product or service.

Essential Job Functions:

Review batch records for accuracy and conformance with standard operating procedures

Confirm that quality control results are within acceptable limits

Report variances, errors, and deviations to quality assurance

Compile and report performance metrics

Support quality issues in manufacturing

Coordinate problem-solving activities, including solution implementation

Execute product release

Conduct document control activities as necessary

Qualifications and Experience:

Previous experience with quality control or quality assurance in a regulated environment required

Excellent communication and interpersonal skills

Strong Attention to detail and analytical skills

Proficiency with Microsoft Office, specifically MS Excel, and general office equipment

Knowledge of relevant regulations, such as FDA regulations and ISO 13485:2016 preferred

Ability to work in an efficient and compliant manner

Ability to work independently and collaboratively in a team setting

Physical Demands:

Ability to sit or stand for long periods of time

Ability to lift, bend or move up to 20 pounds

Ability to work 12-hour shift

Ability to adjust work schedule to meet deadlines and deliverables

Compensation:

$28-34 hourly, Depending on qualifications and experience

Shift Differential

Paid Vacation

Paid Holidays

Paid Sick Leave

Partial Payment by Company of Group Health Insurance

401(k) with limited company matching

Qualifications

Quality Assurance Associate – Weekend Shift

The quality specialist will play a critical role in ensuring compliance with ISO and FDA regulations in our Class II/Class III medical device development and manufacturing processes.

Organizational Competencies & Cultural Values:

The mission of every employee at Osypka Medtec is to serve, support, and improve the lives of our patients and customers by adding value through innovative quality medical devices and services.

Our vision is to be a leading medical company in the development, production, sale, and marketing of permanent and temporary devices and services around the world.

All employees are expected to provide customer service, communicate in an effective manner both verbally and in writing, display professionalism and integrity, as well as work efficiently, effectively and accurately. Employees should take the initiative, solve problems, display good judgment, and take ownership for delivering a high-quality product or service.

Essential Job Functions:

Review batch records for accuracy and conformance with standard operating procedures

Confirm that quality control results are within acceptable limits

Report variances, errors, and deviations to quality assurance

Compile and report performance metrics

Support quality issues in manufacturing

Coordinate problem-solving activities, including solution implementation

Execute product release

Conduct document control activities as necessary

Qualifications and Experience:

Previous experience with quality control or quality assurance in a regulated environment required

Excellent communication and interpersonal skills

Strong Attention to detail and analytical skills

Proficiency with Microsoft Office, specifically MS Excel, and general office equipment

Knowledge of relevant regulations, such as FDA regulations and ISO 13485:2016 preferred

Ability to work in an efficient and compliant manner

Ability to work independently and collaboratively in a team setting

Physical Demands:

Ability to sit or stand for long periods of time

Ability to lift, bend or move up to 20 pounds

Ability to work 12-hour shift

Ability to adjust work schedule to meet deadlines and deliverables

Compensation:

$28-34 hourly, Depending on qualifications and experience

Shift Differential

Paid Vacation

Paid Holidays

Paid Sick Leave

Partial Payment by Company of Group Health Insurance

401(k) with limited company matching