Finished Goods Quality Control Technician

BEPC Inc. needing a dedicated employee:

Get paid every week.

Insurance after 90 days.

Department: Quality Assurance

ESSENTIAL FUNCTIONS/DUTIES and RESPONSIBILITIES:

• Read, interpret and report results, performs trend analysis as required.
• Meets functional area goals and yearly strategic imperative project timelines.
• Assures optimum control of quality so that raw material and/or finished products conform to existing requirements, thus assuring process performance and compliance against Ethicon’s Quality Systems Regulation (QSR), Good Manufacturing Practice (GMP) and ISO requirements for the manufacturing process.
• Support internal and external audits and inspections.
• Performs non-conformance investigations including documentation within the non-conformance, CAPA and internal audit systems.
• Cross-trains to support other functional areas.
• Plan and organize assignments to ensure completion of projects in a timely fashion after receiving minimal instructions as to content and objective.
• Support special projects.
• Utilize failure analysis tools (i.e. 5M analysis) to conduct robust investigations.
• Recommends, amends and analyzes sampling procedures, test methods, standard operating procedures, and/or inspection measures in order to lean processes or simplify current practices.
• Provide training and education to peers and support groups as needed.
• Comply with all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001).
• Assist Quality Engineer on day-to-day activities.
• Utilize document change control system to own periodic review and Standard Operating Procedure (SOP revisions.
• Support Kaizen’s with cross-functional teams to ensure causes of non-conformance are identified and understood and that sound corrective/preventive actions are implemented.
• Performs raw material, tooling and/or in-process tests and reviews.
• Exercise initiative and ingenuity to deal with varying circumstances, changing conditions and proceed when general instructions and established methods indicate action to be taken, referring unusual problems to supervisor performing activities.

OTHER RESPONSIBILITIES:

• Support, understand and adhere to continuous improvement principles by identifying, evaluating and resolving problems.
• Comply with company policies, procedures and the intent of the company Credo.
• Support continuous improvement, improved cycle times, safety, cost reductions and customer satisfaction.
• Complete training programs and certifications as required.
• Coordinate material disposition inspections, process operations and non-conforming material movement from other departments and throughout the designated area. Place an emphasis on meeting customer demands.
• Comply with established safety procedures and policies, with the intent of maintaining a safe working environment. Keep area clean and orderly.
• Maintain strong partnerships with Manufacturing, Engineering, Quality Assurance and maintenance teams.
• Understand and comply with permit/regulatory requirements.
• Performs other work related duties assigned by QA Manager of Operations or Quality Engineer.

EDUCATION and/or EXPERIENCE:

• Associate’s degree in Engineering or a related technical discipline is preferred.
• A minimum of 4 years of related quality assurance experience (Manufacturing, Production, Engineering, Quality) in a regulated environment is preferred.
• Experience in the QSR/ISO regulated Medical Device industry is preferred.
• A minimum of a High School diploma, G.E.D. or equivalent required.

KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES and LANGUAGES

• Must be self-motivated and capable of completing job duties with limited supervision.
• Knowledge of JD Edwards (JDE), Laboratory Information Management Systems (LIMS) and System Control and Data Acquisition (SCADA) preferred.
• Knowledge of Process Excellence/Six Sigma concepts/tools is preferred.
• Must be proficient in the preparation of technical reports and presentations.
• Knowledge of Microsoft Word, Excel and Outlook required.
• Knowledge of statistical data analysis tools (e.g. Minitab) preferred.
• Knowledge of Good Manufacturing Practices (GMPs) preferred.
• Experience with investigation tools (e.g. DMAIC, Fishbone Analysis, 5 Whys) preferred.
• Must have strong communication, interpersonal and influencing skills.
• The ability to interact with technical peers, manufacturing associates and all levels of management in a cross-functional team environment is required.
• Must have strong analytical problem-solving skills.
• Maturity and ability to display a high level of professionalism is required.
• Must be able to speak, comprehend, and write English.
• ASQ certification is preferred.

PHYSICAL DEMANDS

The ability to work overtime, off-shift hours and some holidays as needed by business is required.

WORKING CONDITIONS

1. The noise level in the work environment is usually moderate.
2. Associate is required to wear gowning or other PPE as per established Safety and Quality Procedures.