QA Engineer Process Control

SUMMARY

The position requires someone who has expertise and knowledge in Statistical Process Control (SPC). Responsible for maintaining reject trending analysis. Analyze trends and collaborates to investigate trends, conduct root cause analysis and lead corrective actions for processes and products. Develop and analyze statistical data and specifications to establish product and process capabilities.

This position will work with the following departments in order to drive process improvements in order to prevent repeat non-conformances.He/She will work with Operations, Quality, Engineering, Continuous Improvement, IT, Materials Management and external customers.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Perform statistical analysis of data on CAPA reports.
• Establish a process where an in-control and out-of-control process is characterized and utilized to periodically monitor process control and act if necessary.
• Responsible for maintaining reject trending analysis and apply process capability measures.
• Assists in identifying root causes and coordinate corrective action to quality issues on the packaging floor.
• Participate in equipment process and performance capability studies, including identifying characteristics, specifications and tolerances, developing sampling plans for such studies and establishing statistical control.
• Application of various statistical and problem-solving tools as part of analysis of data, issues, non-conformances or improvement opportunities.
• Knowledge in both variable and attribute control charts (frequentist statistics, along with associated knowledge of OC curves, probabilities, ARL, etc.)
• Knowledge of attribute control charts (Operating Characteristic curves, probabilities, ARL, etc.).
• Strong working knowledge in sampling standards for attributes and variables sampling plan.
• Facilitate the FMEA with the support of SME’s from relevant functional departments. Align rating with client support. Assign actions arising for implementation.
• Involvement in FMEA activities and risk mitigation assessments.
• Collaborate with Quality, Engineering, Operations and other functions to support the in process improvement initiatives.
• Understand descriptive statistics, including the appropriate use of test statistics, and distinguish between various sampling characteristics and methods of a measurement system.
• Participate in customer audits as requested by Senior Management that relates to process control.
• Familiarity with basic tools for quality (i. e. check sheet, control chart, pareto chart, histogram, scatter diagram).

SUPERVISORY RESPONSIBILITIES:

No supervisory responsibilities.

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, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Problem solving, attention to detail, organizational, and communications skills; manual dexterity and familiarity with quality and engineer testing tools and procedures.

EDUCATION and/or EXPERIENCE:

Bachelor’s Degree in Engineering or Mathematical discipline is required with four to six years of related experience and/or training.

At least one (1) outside certification of quality engineers (i.e. American Society for Quality CQE, CSSGB, etc.) is required.

• Strong background in process control and statistical sampling techniques preferred.
• An ability to understand and apply towards Quality Engineering tasks, mathematical concepts especially as it relates to statistics and probability. Ability to apply mathematical operations to such tasks as frequency distribution, determination of tests, analysis, sampling, and process capabilities.
• Strong working knowledge of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), and DOE (Design of Experiments).
• Proficient in Microsoft Office (Word, Excel, Access, PowerPoint), Microsoft Project, Statistical Software (MiniTab).
• Background experience with medical device, pen assembly, sterilization, vial/syringe labeling, bottling, pouching, blistering, and serialization processes.
• Strong leadership skills with the ability to challenge, influence, and build consensus.
• Must be able to analyze data and communicate issues, findings and processes and ideas in a clear, concise, technically-proficient manner.
• A good knowledge of available technology in pharmaceutical.
• An interest in keeping up with new technologies as they develop.
• An ability to communicate well with other engineers and non-technical people, both written and spoken.
• Ability to work both independently and as a team member.
• Able to multitask, prioritize, and manage time efficiently.
• Able to analyze problems and strategize for better solutions.
• General Knowledge on ICH Q9 (Pharmaceutical Risk Management Guidance).
• General Knowledge on ISO 14971 (medical device risk management standard).
• General Knowledge of FDA regulations related to cGMP’s is required.
• General knowledge of statistics is desired.

LANGUAGE SKILLS:

Ability to read and interpret documents such as compliance regulations, validation protocols, standard operating procedures, safety rules, operating and maintenance instructions and technical manuals. Ability to write detailed technical reports. Ability to speak effectively before groups of customers or employees of organization.

MATHEMATICAL SKILLS:

Ability to use college level mathematics to perform detailed calculations. Must have a thorough understanding of statistics and be able to perform detailed statistical data analysis.

REASONING ABILITY:

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

COMPUTER SKILLS:

Knowledge of Microsoft Office Suite, including Excel, Word, Project and Access. Familiar with ERP systems. Knowledge of statistical software packages (MiniTab).

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts. The noise level in the work environment is usually moderate.

Travel between site locations required. Occasional travel to Sharp’s multiple sites required <20%.