Supplier Quality Compliance Engineer - San Angelo, United States - BEPC Incorporated

BEPC Incorporated San Angelo, United States

4 weeks ago

Description

BEPC has an open position for a Remote Supplier Quality Compliance Engineer

Pay & Benefits:
$40/hr. + Medical, Dental, Vision and Life Insurance

The Supplier Quality Compliance Engineer ensures the execution of quality system compliance activities associated with the receipt and acceptance of robust supplier audit responses for identified supplier audit observations.

The Supplier Quality Compliance Engineer performs these activities to applicable quality management system standards for fortune 500 Medical Device Companies.

The Supplier Quality Compliance Engineer addresses supplier audit responses for suppliers across different industries such as medical device, Pharmaceutical, Biotechnology, Microbiology and Sterilization Sciences as needed to meet customer requirements.

This individual will be responsible for supporting external inspections of External Manufacturers and Suppliers. They will also be responsible for supporting internal audits of the client's Compliance program. Supports in the management, tracking to closure of External Manufacturers and Suppliers commitments to mitigation of identified risks.

Supports in the completion of Follow Up reports related to the tracking and completion of External Manufacturing commitments taken to mitigate identified risks.

Responsibilities

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and client procedures and guidelines, this position:

Assists in the development, implementation and continuous improvement of the client's Compliance program.
Ensures timely mitigation of risks identified through Supplier Audit Program.
Requests and reviews documentation related to Supplier Audit Response for identified audit observations

Assures that related client Compliance Quality Records are updated in a timely manner and are compliant with company procedures and policies.

Ensures timely completion of activities related to training.
Proactively engages with external partners to develop a robust supplier corrective action response.
Issues Follow Up reports in accordance with client procedural requirements.
Identify process improvements related to standard operating procedures and systems to mitigate risk and drive a quality culture.
Complies with policies, procedures, training requirements and company and regulatory rules and norms.

Performs according to the company's quality policy and corporate rules in all business activities with providers and customers within and outside the company.

Escalates abnormalities and business critical information to the client's Compliance Leadership.
Maintains quality records where applicable per client records retention procedures.
Responsible for ensuring personal and client Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Other Duties

Other duties may be assigned as required by BEPC management.

Competencies

Expertise on/detailed knowledge of regulatory requirements in the FDA/ISO/Health Authority regulated industry (medical devices or pharmaceutical), with the ability to relate them to business/quality issues.

Excellent prioritization skills
Excellent written and oral communication skills as well as report writing
Strong collaboration and influence skills to partner effectively both internally and externally
Experience in the Medical Device industry or medical field
Able to enter data on spread sheet and database applications
Ability to make the complex clear and easily understood by others
Knowledge of ISO 13485 and 21CFR 820
Quality system auditor qualifications desirable, e.g. ASQ CQA or CBA, ISO 9001/13485 lead auditor
Ability to work in a sometimes stressful fast paced environment

Supervisory Responsibility

This position is an individual contributor position.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as laptop computers and smartphones.

Position Type/Expected Hours of Work

This is a full-time position, and hours of work typically Monday through Friday, 8:00 a.m. to 5:00 p.m.

However, agility and quick response time to customer and employee requests may be required at other times to include evening and weekends.

This position works remotely.

Travel This position requires minimal to no travel, e.g.

Required Education And Experience

Bachelor's degree or equivalent required; concentration in Engineering or technical field preferred

5-8 years or more experience in a FDA regulated industry (pharmaceutical or medical devices) or another highly regulated industry is required.

AAP/EEO Statement BEPC Inc.

policy is to affirmatively implement equal opportunity for all employees and applicants for employment without regard to race, color, religion, sex, national origin, disability, military status, genetic information, or any other basis prohibited by law.

Additionally, BEPC Inc.

does not discriminate against an employee or applicant who acts to oppose such discrimination or participates in the investigation of a complaint related to discriminatory employment practice.

Employment decisions will be made on the basis of each applicant's job qualifications, experience, and abilities.

Date Added:
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