Quality Engineer - Consumer Goods

How would you like to work for an innovative, forward-thinking company that manufactures and distributes high quality healthcare products for the world?

If you are passionate about teamwork, are driven by exceeding expectations in all that you do and thrive in an organization that promotes having fun while making a difference, join us!

As a privately held company since 1991, we at BioFilm, research, develop, and manufacture the best healthcare products to enhance intimate activities, quality of life and protective wellness. In beautiful Vista, California, our facility is the hub!

You’ll work with leading researchers, engineers and scientists in a culture that embraces ingenuity.

What we offer:4-day work weeks – every Monday off!

• Health, dental, and vision insurance (with employee contribution) plus
• Health Reimbursement Account and Flexible Spending Account options available
• Matching 401K and profit-sharing
• Discretionary annual bonuses based on profits
• Generous PTO and holiday schedule including paid time off from Christmas Eve to New Year's Day
• Alternative Work Week: BioFilm works an alternative work schedule of four 9.5-hour days. You will be likely assigned to one of the following schedules, 6:00 am – 4:30 pm -or- 7:00 am – 5:30 pm, with one hour for lunch.
  

Manufacturing Engineer...

Purpose of Position: The Quality Engineer (QE) works with the internal manufacturing engineers, supply chain and contract manufacturers to continuously improve performance of key system components (refine life cycle, reduce scrap, improve/repair processes) by implementing process controls and developing quality control plans. Responsible for the overall Quality, Risk, and Performance Management of suppliers and contract manufacturers. The QE tracks data, identifies improvement projects, and manages cross functional implementation to improve performance in Production and Supplier Quality. The QE has high upstream focus to limit cost and time investment maximizing Product Quality.

5 Key Roles:

1. PRODUCTION QUALITY, INCLUDING MONITORING AND CONTINUOUS IMPROVEMENT BY IMPLEMENTING & DEVELOPING QUALITY CONTROL PLANS, PROCESS CONTROLS AND UTILIZING APPROPRIATE QUALITY TOOLS.

2. PERFORMANCE MANAGEMENT OF SUPPLIERS AND CONTRACT MANUFACTURERS, INCLUDING LEADING SUPPLIER AUDITS.

3. DRIVING EFFECTIVE MANUFACTURING EQUIPMENT QUALIFICATIONS, PROCESS CAPABILITY EVALUATIONS AND PROCESS VALIDATIONS, INCLUDING COLLABORATING WITH THE MANUFACTURING ENGINEERS IN PROTOCOL GENERATION, REVIEW AND EXECUTION.

4. ADMINISTRATION OF THE RISK MANAGEMENT PROGRAM, INCLUDING DEVELOPING PLANS, RISK ANALYSIS AND FMEAS.

5. LEAD IN ROOT CAUSE INVESTIGATIONS AND DRIVING EFFECTIVE CORRECTIVE AND PREVENTATIVE ACTIONS.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Maintain cooperative, diplomatic working relationships with co-workers, supervisor and the public.

• Work as part of the team and collaborate with co-workers and colleagues.

• Responsible for reading, understanding and following Quality Management Systems documentation for each function performed.

• Responsible for working in compliance with Quality Systems Regulations (QSR), safety and all other training.

• Provide feedback and recommendations for company improvement opportunities.

• Adhere to and support BioFilm’s Corporate Policies and Procedures.

• Actively works to improve processes in the company and its relationship to the community.

PRODUCTION/SUPPLIER QUALITY

• Promote the use of Statistical Process Control (SPC), Control Plans and continuous improvement techniques to help them reduce variability, achieve process control, and improve Quality.

• Initiate, track and drive internal Manufacturing and Suppliers Corrective and Preventative Actions (CAPA/SCARs) to ensure complete and effective root cause analysis and corrective action implementation.

• Evaluate and qualify new suppliers and contract manufacturers. Monitor and re-evaluate Approved Suppliers (ASL) assuring continued Supplier conformance to specifications and driving continuous improvement. The evaluations may include Supplier Surveys, Risk Assessments, Supplier Audits, Quality Agreements, Audit Reports, Data Analysis, Material Qualifications, and First Article Inspections.

• Develop positive relationships and effective lines of communication with suppliers, including coaching, driving partnership-oriented arrangements. Directly address supplier issues by setting up conference calls, BioFilm site meetings and/or visiting supplier sites.

• Help establish and deploy effective Closed-Loop Quality Management Systems that integrates all Quality modules (Audits, Non-conformance tracking, CAPA, Deviations, Change Control, and Training).

• Work closely with the Purchasing Group to establish and maintain Supplier Quality Scorecards (that includes Delivery, Cost, Customer Service, Capability, and Quality).

• Identifies opportunities for reduced inspection of purchased materials based on risk and quality performance.

• Implement Production process controls to mitigate potential on-line failure modes or critical raw material defects.

• Participate as a member of the Material Review Board to review and disposition Supplier and Production related Non-conformances.

• Lead regular meetings to discuss Supplier Quality Topics, including KPIs, Scorecards, Issues, Audit Findings, and OFIs.

ANALYSIS

• Responsible for gathering and organizing of data for analysis. Make informed decisions based on data.

• Trend and analyze data collected to ensure requirements are met and identify opportunities for improvement.

• Lead or assist with root cause investigation for non-conformances, customer complaints, and CAPAs.

DOCUMENTATION

• Assist Quality Manager in creating, updating, revising, reviewing and maintaining all Quality/Supplier documentation and Device History Records (DHR’s), including procedures and forms, Quality Agreements, change notification agreements, auto-generated reports, and audit reports.

• Assist in the Quality Systems administration assigned by the Quality Manager.

PRODUCT DESIGN/DEVELOPMENT

• Participate as a core member of development teams to assure processes are in place to design and release highly reliable products.

• Manage and maintain Design History Files (DHF).

• Provide Quality Assurance expertise and guidance for New Product Development/Design Control, Risk Management, Manufacturing, Supplier & Material Qualification, and Product Quality.

• Drive and lead design verification and validation activities such as process validation, raw chemical qualification, and first article inspection.

• Develop Risk Management Plans and maintain Risk Management Files. Manage and lead Risk Management activities such as dFMEA, pFMEA, uFMEA, Risk Analysis,. Apply Risk Management Process to Supplier Management decisions.

• Assist Manufacturing Engineers and Suppliers in the creation and review of equipment qualifications (IQ/OQ/PQ), drawings/die-lines, sampling plans, process validations, capability studies, and process control implementation.

SAFETY

• Responsible for maintaining a clean and safe work environment by identifying all safety hazards and recommending corrective actions when necessary.

• Responsible for utilizing proper lifting and material movement techniques at all times.

• Performs all other related job duties as assigned by the Quality Manager.

QUALIFICATIONS AND EDUCATION REQUIREMENTS:

• BS IN ENGINEERING, CHEMISTRY, BIOLOGY, BIOTECH, CHEMICAL ENG, OR OTHER SCIENCE RELATED FIELD

• 3+ YEARS OF EXPERIENCE IN A SUPPLIER OR PRODUCTION QUALITY ENGINEERING CAPACITY.

• EXPERIENCE WORKING IN A REGULATED ENVIRONMENT WITH A STRONG KNOWLEDGE OF MEDICAL DEVICE FDA 21 CFR 820/ISO 13485:2016 REQUIREMENTS.

• WORKING KNOWLEDGE OF QUALITY SYSTEMS AND QUALITY RELATED TOOLS, SUCH AS FMEA, SPC, CPK, AQP, DOE.

DESIRED EXPERIENCE:

• PRIOR SUPPLIER AND INTERNAL AUDITING EXPERIENCE.

• KNOWLEDGE OF 21 CFR 210/211 REGULATIONS.

• PROCESS VALIDATION AND IQ/OQ/PQ EXPERIENCE.

• AQL/STATISTICAL SAMPLING EXPERIENCE.

• DESIGN CONTROL EXPERIENCE.

• DESIGN V&V EXPERIENCE.

• ASQ CERTIFICATION, CQE, CSQP, AND/OR CQA OR LEAD AUDITOR CERTIFICATION.

• KNOWLEDGE OF ISO 14971.

• PRACTICE IDENTIFYING, MITIGATING, AND RESOLVING RISKS (FMEA, FTA).

• LEAN SIX SIGMA TRAINING PREFERRED

• KNOWLEDGE OF STATISTICAL SOFTWARE

• SCAR, CAPA, NCMR, AND CUSTOMER COMPLAINT INVESTIGATION AND ROOT CAUSE ANALYSIS EXPERIENCE

• EXPERIENCE WITH PACKAGING SUPPLIERS AND CONTRACT MANUFACTURERS.

• PROJECT MANAGEMENT SKILLS.

LANGUAGE SKILLS

• ABILITY TO READ, WRITE AND SPEAK FLUENT ENGLISH.

JUDGMENT/REASONING ABILITY:

• ABLE TO RECOGNIZE AND RESOLVE PROBLEMS QUICKLY USING SOUND JUDGMENT AND DIPLOMACY.

OTHER SKILLS AND ABILITIES:

COMPUTER SKILLS

• KNOWLEDGE OF AUTOCAD AND SOLIDWORKS.

• COMPUTER LITERATE IN MICROSOFT WINDOWS AND OFFICE.

• MICROSOFT PROJECT AND ACCESS EXPERIENCE IS PREFERRED.

• ADVANCED MICROSOFT EXCEL FOR DATA ANALYSIS IS PREFERRED.

• MICROSOFT DYNAMICS NAV OR ERP EXPERIENCE IS A PLUS.

• MASTER CONTROL EXPERIENCE IS A PLUS.

COLLABORATION TOOLS EXPERIENCE IS A PLUS GENERAL SKILLS

• DETAIL ORIENTED.

• ANALYTICAL ABILITIES.

• GOOD ORGANIZATIONAL SKILLS.

• ABILITY TO WORK AS PART OF A TEAM.

• STRONG PROBLEM-SOLVING/ANALYTICAL SKILLS.

• ADVANCED ORAL AND WRITTEN COMMUNICATION SKILLS, INCLUDING THE ABILITY TO WRITE TECHNICAL REPORTS AND PRESENTATIONS.

• RELATIONSHIP BUILDING SKILLS.

• SELF-STARTER WITH THE ABILITY TO QUICKLY LEARN ABOUT NEW PROCESSES WITH VERY LITTLE INFORMATION PROVIDED.

• EXCEL MACRO PROGRAMMING SKILLS.

• FLEXIBILITY TO CHANGE DIRECTION FREQUENTLY AND WITH LITTLE NOTICE.

• ABLE TO HANDLE MULTIPLE TASKS SIMULTANEOUSLY.

• EXCELLENT PLANNING AND ORGANIZATION ABILITIES.

• ABLE TO COMPLETE PROJECTS UNDER TIGHT DEADLINES, EVEN WHEN THERE ARE COMPETING REQUIREMENTS AND CHANGES IN ASSIGNMENTS (TIME MANAGEMENT AND PRIORITIZATION SKILLS).

• ABILITY TO ROTATE THROUGH DIFFERENT AREAS OF THE QUALITY GROUP.

COMMUNICATION SKILLS

• STRONG WRITTEN AND VERBAL COMMUNICATION SKILLS.

• STRONG INTERPERSONAL SKILLS WITH THE ABILITY TO USE TACT AND DIPLOMACY.

• EXCELLENT COMMUNICATION AND NEGOTIATION SKILLS.

• ABILITY TO EFFECTIVELY COMMUNICATE WITH MANAGER AND EMPLOYEES WITHIN THE DEPARTMENT IN ORDER TO MAINTAIN AND EFFICIENT WORK ENVIRONMENT.

PHYSICAL DEMANDS:

• ABILITY TO SQUAT AND LIFT UP TO 50 POUNDS.

• GOOD VISUAL COLOR PERCEPTION.

• ABLE TO STAND, STOOP AND BEND.

• ABILITY TO WALK AND STAND ON CEMENT FLOORS FOR LONG PERIODS.

• ABLE TO WORK IN A WAREHOUSE ENVIRONMENT WITH NO CENTRAL AIR OR HEAT.

• ABLE TO SIT AT DESK AND USE/VIEW COMPUTER FOR PROLONGED PERIODS OF TIME.

• ABLE TO WEAR LATEX GLOVES, HAIR COVERS, LAB COATS AND GOGGLES.

WORK ENVIRONMENT:

• FAST PACED WITH MULTI-LEVEL DISTRACTIONS.

• NON-SMOKING.

• PROFESSIONAL, YET CASUAL WORK ENVIRONMENT.

• CLEAN PRODUCTION AREAS; LAB COAT, GLOVES, AND HAIRNET REQUIRED.

• PRODUCTION, LAB, AND WAREHOUSE ENVIRONMENT.

SPECIAL CONDITIONS:

• ABILITY TO WORK OVERTIME AS NEEDED.

• POSITION WILL REQUIRE SOME TRAVEL (LESS THAN 15% ANNUALLY)