EP Quality Engineer (Healthcare)

OBE Wausau EP                          EP Quality Engineer                                FLSA: Exempt

OBE (Wausau EP) is looking for a Quality Engineer to develop and work with a team that is building a complete Quality Management System. This position will be heavily involved with the TPS/OpEx process and working with control plans, process flow diagrams, and PFMEA processes. They will also participate in the development, maturing and monitoring of end-to-end business processes that will ensure effective process development, engineering OTCC (On Time Complete & Correct) and process manufacturing systems. This will include problem identification, analysis of issues and opportunities, process measurement, and development, and implementation of planned process changes using formal, structured methods.

Essential Duties and Responsibilities:

• Prepares reports by collecting, analyzing, and summarizing data for company's KPI's in Quality and COPQ.
• Identify problems in production areas and implements solutions using root cause analysis tools.
• Ownership of the Quality System which includes Control Plans, Process Flow Diagrams and PFMEA processes.
• Create and maintain quality documents required for QMS compliance.
• Schedule and lead MRB meetings reviewing non-conforming materials.
• Create inspection systems for incoming materials for requirements.
• Review testing processes and data for SPC parameters.
• Assist in management of external suppliers and ownership of issue resolution.
• Assist in development of quality and validation plans.
• Lead/Participate in Quality Audits.

Skills, Knowledge, and Abilities:

To perform this job successfully, the incumbents will possess the skills, knowledge, and abilities to perform each duty proficiently.

• Previous work experience as a Manufacturing or Quality Engineer.
• Hands-on experience with Quality Management Systems (QMS) and testing methodologies.
• In-depth understanding of technical documentation.
• Familiarity with statistical analysis.
• Great attention to detail and problem-solving abilities.
• Strong analytical and problem-solving skills.
• Strong communication skills.
• Proficiency in using manufacturing management software (e.g., ERP systems).
• Knowledge of ISO9001 Quality Management System.
• Safely performs tasks and adheres to all safety policies and procedures that are essential functions of this job.
• Practices, promotes, and supports OBE Virtues; Safety, Integrity, Performance Culture, Teamwork, Customer Centric, and Agility.
• Ability to coordinate and motivate multi-talented production employees in a factory setting, sometimes requiring extended working hours.
• Ability to create professional, effective communications that present with proper grammatical structure and spelling.
• Demonstrates consistent, team leading punctuality and attendance habits.

Requirements:

• BS in Mechanical Engineering, Industrial Engineering, Quality Assurance, Process Engineering, or relevant field experience.
• 5+ years of industry experience.
• Strong knowledge of quality tools used in the industry.
• Analytical and quantitative approach to problem solving.

Work Environment:

Work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this position.

• The Quality Engineer with work in the office and plant environments.
• Noise levels in the plant environment are moderately loud.
• Regularly works near manufacturing equipment and production materials.
• Some work areas produce dust and metal fragments.
• The production plant is heated during the winter, but conditions could be colder in the winter and warmer in the summer.

Physical Activities/Demands:

• The Ability to stand on your feet for 8 to 10 hours per day on a concrete floor.
• Ability to work in an office setting environment.

Plant PPE Requirements:

Hard-hat, ear protection, high-visibility vest, arm guards, gloves, face shields (if position requires), and met guards (if position requires). PPE should always be worn correctly and maintained as per safety regulations.

What OBE Offers You:

• Competitive pay.
• Paid time off.
• 10 company-sponsored holidays (inclusive of 2 floating holidays).
• Market competitive 401k with match.
• Industry-leading medical, dental, and vision benefits.
• Short-term and long-term disability coverage.
• Life Insurance.
• Tuition Reimbursement.
• Employee Recognition Program; events and anniversary gifts

 

OBE is an Affirmative Action and Equal Opportunity Employer.

EEO/Vet/Disability

OBE is an E-Verify Employer

 

 

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c) Quality Control