Lubrizol QA Supervisor in Franklin, Wisconsin
The Quality Control Supervisor is primarily responsible for assuring product quality and compliance (raw materials, development products, WIP and finished goods) through the development, implementation and monitoring of appropriate processes, people, tools, metrics and goals .
DESCRIPTION OF ESSENTIAL DUTIES:
Responsible for establishing Quality Control testing, sampling and control strategies such as SPC.
Analyzes product and process quality data to identify and make recommendations for meeting organizational Quality objectives (improved product quality, scrap reduction, compliant reduction, rework reduction, etc.)
Acts as technical advisor on Quality Control matters.
Overall responsibility and ownership of material release and final disposition activities.
Establishes Measurement Systems Analysis processes.
Establishes goals and metrics related to people, processes and products for the Quality Control Department.
Provides input to the development of departmental and corporate performance objectives.
Identifies hires and develops Quality Control personnel to meet company and departmental objectives.
Directs the activities of the Quality inspection team.
Plans, promotes, and organizes training activities related to product quality.
Direct Process Owner for Process Controls and NCR process.
Supports technical contract review, validation and revalidation activities for product development process.
Reviews and approves applicable Quality System Documents, Deviations, Process Change Orders (PCOs).
Establishes Incoming Inspection Requirements for supplied products and materials.
Supports customer and other regulatory bodies’ audits and inspection.
Other duties as assigned.
DESCRIPTION OF MARGINAL DUTIES:
- Observe and promote Company standards and policies on safety, quality and productivity.
DIRECT REPORTS :
- Quality Inspector(s)/Technician(s)
HIRING GUIDELINES : (To perform job successfully, and individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or ability required/preferred).
Successful completion of four-years of high school, or equivalent, plus completion of four years of college with a bachelor’s degree preferably in the engineering or science fields.
Five to seven years of experience, or any combination of education and experience that provides equivalent knowledge, skills and abilities.
Experience with Measurement Systems Analysis, Statistical Process Control, Blueprint analysis and Process Validation
Certified Quality Engineer (ASQ) (preferred)
Certified Quality Manager (ASQ) (preferred)
Knowledge of ISO 13485:2003 at mastery level and FDA 21 CFR Part 820 at proficient level (preferred)
Six Sigma Black Belt (preferred)
Lean Manufacturing (preferred)
Finished medical device company experience (preferred)
Quality engineering/control experience
Direct management/supervisory experience
Knowledge of advanced statistical concepts
Excellent (written and verbal) communication and effective human interaction skills.
Flexible to change, and possess a high degree level of integrity and “can do attitude”.
Willing to work in a team environment and contribute to group goals
Ability to receive and provide instructions in a positive manner.
PHYSICAL DEMANDS: (The physical demands described here are representatives of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function. The phrases “occasionally”, “frequently” and “constantly” correspond to the following definitions: “occasionally” means up to 33% of working time, “frequently” means between 34%-66% of working time, and “constantly” means 67% and more of working time. Additionally vision requirement definitions are as follows: close vision-clear vision at 20 inches or less, distance vision—clear vision at 20 feet or more, color vision-ability to identify and distinguish colors, peripheral vision-ability to observe an area that can be seen up and down or to the left and right while eyes are fixed on a given point, depth perception-three-dimensional vision-ability to judge distances and spatial relationships and ability to focus—ability to adjust the eye to bring an object into sharp focus ).
This physical demand level for this job is considered light with occasionally lifting 10-25 pounds. Exposure to lifting more than 25 pounds is rare (if ever).
The employee may occasionally be subject to dynamic standing/walking with constant exposure to static standing/sitting and using hands to finger or handle/touch. The employee will rarely (if ever) be subject to pushing/pulling (rough poundage of force), floor to knuckle lift/lower, knuckle to shoulder lift/lower, shoulder to overhead lift/lower, sustained bending, use foot/feet to operate machine, climb or balance, stoop, kneel, crouch or crawl, reach above shoulders or repetitive bending or squatting.
The following vision requirements apply: close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
WORK ENVIRONMENT: (The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities).
The employee will occasionally be exposed to working near moving mechanical parts. The employee will rarely (if ever) be subject to wet humid conditions, working in high precarious places, fumes or airborne particles, toxic or caustic chemicals, outdoor weather conditions, extreme cold or heat, risk of electrical shock or travel on company business. The noise level is considered moderate (business office, computer printer, light traffic level) and occasionally considered loud if near operating production equipment.
The employee will be required to wear appropriate Personal Protective Equipment such as: safety glasses in the designated areas, hairnet/beardnet and jumpsuit when on production floor.
The employee will frequently use a PC with Microsoft Office products, and occasionally use Minitab (or other statistical software), EQMS and MSA.
The above statements reflect the general details necessary to describe the principle functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.
Nearest Major Market: Milwaukee
Job Segment: Manager, Engineer, Electrical, Law, Inspector, Management, Engineering, Legal, Quality