Quality Engineer

Position Summary

• A member of the Quality Engineering team that will partner with both Internal and external customers, to ensure that we meet all quality and regulatory requirements.
• A fast-paced position that will participate in a wide array of quality events that will highlight ability to problem solve, develop technical reports and present information.
• Will utilize appropriate investigative tools, good engineering design and GMP’s when investigating issues and recommending corrective actions.

Universal Accountabilities

• Be accountable for meeting all assigned Quality Engineering deliverables.

• Ensure the quality of products produced is consistent with EPC Quality standards.
• Ensure the Quality Unit is functioning efficiently by assessing current processes and identifying ways to streamline or improve. 
• Ensure the timely closure of Corrective Action Preventative Action (CAPA) investigations, on-going investigations and other non-conformance investigations.
• Support appropriate product development quality related projects: internal and external.   

• Creates and presents reports for management, and other internal groups.
• Ability to effectively communicate with cross functional groups located both externally and internally within the organization.
• Effectively document consumer complaints (customer/consumer) to meet applicable standard operating procedures.
• Knowledge of problem-solving technical problems in a structured method.
• Perform statistical analysis on data sets and be able to interpret results.
• Conducts quality audits on appropriate regulatory and procedural requirements.

Specific Accountabilities

• Ability to effectively interact with and lead cross-functional teams relative to cost improvement projects, NPD projects, and problem solving of quality issues.
• Ability to write, review, revise and approve Quality SOPs
• Ability to write and execute validation protocols and write validation summary reports
• Ability to write risk assessments and deviations

Required Skills and Experience

• BA or BS.
• Two to seven years minimum experience working in a manufacturing environment in a quality related field.
• Two to seven years minimum experience in a regulated business.
• Process or Packaging validation.
• Excellent communication skills, written and verbal.
• Excellent computer skills – Microsoft Office.
• Well organized person.
• Strong technical writing skills.
• Strong problem-solving skills, including root cause analyses.
• Statistics and sampling plans background with DOE experience.

Preferred Skills and Experience

• BA or BS in a technical discipline such as Biology, Chemistry, Engineering, Microbiology or related field..
• ASQ CQE certification or Six Sigma Green Belt preferred.
• Knowledge of cGMPs, standards and regulations as applicable
• QC laboratory experience.
• Strong statistics and sampling plans background with DOE experience

Working Relationships

• Position reports to an Associate Manager or Manager
• Close relationships with Operations, Commercial team, Regulatory/Product Safety, Reliability Engineering, Quality, Post Market Surveillance and R&D

Work Environment

• Ability to work in an office environment
• Ability to work in a production and warehouse environment
• Ability and willingness to travel, as in the execution of the duties of this position the employee may travel up to approximately 10%, or slightly more, of their work time.
• Ability to occasionally work hours outside of normal shift
• Ability to travel overseas as required.
• Exposure to health risks or conditions that may require the use of Personal Protective Equipment

Environmental, Health and Safety Responsibilities

• Conform to safety regulations and procedures to maintain a safe working environment.
• Be aware of and follow the Environmental Policy and EH&S work instructions/procedures that apply to the job.
• Performing every job safely, for the benefit of self, co-workers, contractors, and for the protection of facilities.  This includes the use of required personal protective equipment and use of safely equipment/devices, guarding, as well as safe work practices.
• Immediately reporting every job-related injury or illness, regardless of severity, to a team leader/supervisor
• Assist in investigating incidents as directed.
• Taking necessary actions to correct or stop unsafe conditions or practices.
• Actively participation in safety meeting and training
• Review SDS instructions before working with any chemicals or hazardous materials.

Quality Responsibilities

• Teammates are responsible for their own quality and that of teammates within their span of control.
• Teammates are responsible to follow all established Quality procedures and instructions.
• Teammates are responsible for notifying leadership for corrective action if defects are found and/or parts/processes do not conform to specifications.
• Teammates are responsible for adhering to current Good Manufacturing Practices (cGMP) work rules as they relate to job-specific duties.

Supplemental Information

• This description is based on management’s assessment of the requirements and functions of the job as of the date this description was prepared. It is a general guideline for managers and employees, but it does not purport to be an exhaustive list of all the elements of the job.  Management reserves the right to modify and description at any time, or to vary the duties and responsibilities of the job on a temporary or indefinite basis to meet the production, scheduling, or staffing needs.

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The salary range for this position is $68,000 -$90,000.  Actual base salary offered to a candidate may vary based upon factors including, but not limited to, relevant experience, time in role, base salary of internal peers, prior performance, business sector, and geographic location. In addition to base salary, the competitive compensation package may include, depending on the role, participation in an incentive program linked to performance