Quality Engineer II

Job Description

Mastech Digital provides digital and mainstream technology staff as well as Digital Transformation Services for all American Corporations. We are currently seeking a Quality Engineer II for our client in the Pharmaceutical domain. We value our professionals, providing comprehensive benefits and the opportunity for growth. This is a Contract position, and the client is looking for someone to start immediately.

Duration: 6+ Months Contract

Location: Danbury, CT

Salary: $30-$42/Hourly

Role: Quality Engineer II

Primary Skills: Agile

Role Description: As a Quality Engineer II, you must have at least 2-5+ years of experience.

Responsibilities:

- Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.

- Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution.

- Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.

- Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.

- May ensure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).

- Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.

- Exercises judgment within defined procedures and practices to determine appropriate action.

- Builds productive internal/external working relationships.

- Developing professional expertise, applies company policies and procedures to resolve a variety of issues.

- Normally receives general instructions on routine work, detailed instructions on new projects or assignments.

Essential Duties and Responsibilities:

You may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.

- Model all quality values and coaches’ others on BSH quality system requirements and standards to elevate team's ability to produce high-quality products and implement best practices that emphasize defect prevention, reduction in variation and waste and provide for continuous improvement.

- Provide quality engineering support to Operations, Engineering and R&D in the design and manufacture of medical devices to ensure robust product builds and the production of high-quality products and manufacturing practices.

- Responsible for ensuring that the products produced meet applicable regulatory and quality standards and customer expectations.

- Develops and implements procedures, inspection procedures and test methods in compliance with QMS, Medical Device Quality System Regulation and Medical Device Directive requirements.

- Provides training as required.

- Acts with urgency to Identify and provide timely resolution to quality issues.

- Perform risk assessments and update risk management documentation as required.

- Perform customer complaint investigations, root cause investigations, root cause analysis, problem solving and corrective actions.

- Reviews technical publications, articles and abstracts to stay abreast of technical developments in the industry.

- Investigates and processes Non-Conforming Events. (NCE).

- Prepares reports assessing the suitability and effectiveness of assigned areas of the quality system.

- Active participate in processes and meetings such as MRB, NCE, CAPA and SCAR process.

- Review and approve routine to moderately complex ECO’s product related change orders, engineering studies, sustaining engineering products, specifications, drawings, manufacturing procedures, design process verification and validation documentation.

- Active participant in facility and supplier audits and Notified Body and FDA inspections.

Physical Demands:

- The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Sit; use hands to finger, handle or feel objects, tools, or controls.

Required Skills:

- Excellent computer skills including ability to use word processing, spreadsheet programs and databases

- Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations.

- Excellent technical writing skills with ability to write quality assurance reports and details procedures

- Good presentation skills

- Good interpersonal skills to interact with all levels of the company, sometimes in an adversary role

- Knowledge of GMP and GDP Principles

Beneficial:

- Working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements

- Knowledge of microbiology, molecular biology, biochemistry, chemistry and/or related disciplines

- Understanding of nucleic acid amplification and detection technologies

- Understanding of Scientific Method and statistical analysis

- Knowledge of Oracle and Agile

- Experience in an FDA regulated industry

- Certified Quality Engineer

Education: Bachelor’s Degree (Technical Field Preferred), May have Master’s Degree.

• 2-5 Years with Bachelor’s Degree

• 1-2 Years with Bachelor’s Degree in Technical Field

• 0-2 Years with Master’s Degree

Experience: Minimum 2-5+ years of experience

Relocation: This position will not cover relocation expenses

Travel: No

Local Preferred: Yes

Note: Must be able to work on a W2 basis (No C2C)

Recruiter Name: Purvi Sonker

Recruiter Phone:

Equal Employment Opportunity

Full-time