Engineering Jobs in North Lake, WI

About the role

As an Engineering Project Manager, you will oversee production and automation projects while leading a small team of project managers and engineers. You will serve as the key coordination point between Sales, Production, Quality, Engineering, and Field Service, ensuring projects are delivered on time and meet customer expectations.

This is a hands-on leadership role where you’ll see the direct impact of your work on customer satisfaction, team performance, and operational excellence. Caljan combines cutting-edge engineering with a collaborative, international culture, offering career growth in a global company specializing in material handling and automation solutions.

What You’ll Do

• Lead and mentor a U.S.-based project team (2 project managers + 2 engineers)

• Manage multiple production and automation projects from sales handoff through production completion

• Coordinate cross-functionally to ensure smooth execution across Sales, Production, Quality, Engineering, and Field Service

• Ensure projects meet quality, schedule, and scope requirements

• Maintain strong customer relationships and manage expectations during execution

• Identify and proactively resolve project risks or issues

• Track schedules, resources, and team performance

• Support continuous improvement and adherence to established processes

This role is execution-focused: processes are in place, and your job is to make sure they run efficiently while your team delivers exceptional results.

What You Bring

• Bachelor’s degree in Mechanical Engineering, Automation, or related field

• 5+ years of project management experience in manufacturing, industrial automation, material handling, or engineered product production

• Experience managing small teams (1–5 direct reports)

• Strong understanding of production systems, engineering projects, and technical execution

• Excellent leadership, communication, and organizational skills

• Comfortable managing customer interactions and cross-functional coordination

• Proficiency with Microsoft Project, spreadsheets, and project tracking tools

Why This Role Matters

This is a high-impact, operational leadership role where you will:

• Take full ownership of customer projects from handoff to production completion

• Lead a small team to deliver consistent, high-quality results

• Coordinate across departments to ensure smooth execution and satisfied customers

Compensation & Benefits:

• Salary: $110,00 – $120,000

• Benefits: Caljan offers medical, dental, vision, and 401K with a match.

About Caljan

Caljan is a mid-sized global engineering company specializing in automated material handling solutions. With operations across Europe, the UK, and the U.S., we combine global reach with an entrepreneurial mindset. Our teams work closely across regions to deliver technically advanced, customer-focused solutions.

Under the direction of the Engineering Manager, the Design Engineer is responsible for the support of new and existing products. This support may include, but is not limited to, product development, prototype generation, laboratory testing and problem solving, from concept to production.

ESSENTIAL DUTIES AND RESPONSIBILITIES

All employees work to satisfy the customer. Each department has expected core responsibilities, but these responsibilities do not define us. Rather, they simply provide a starting point where we work to satisfy the customer, and continuously improve ourselves, others, and the organization.

· Responsible for understanding the customer’s technical scope of work and delivering designs that meet or exceed expectations.

· Analyzes engineering sketches, specifications, data, drawings and models to determine design factors as well as tolerancing.

· Uses computer aided design tools for two- and three-dimensional magnetic analysis, computation fluid analysis, structural finite element analysis to develop and optimize designs.

· Designs for manufacturability

· Uses lab equipment such as force testers, multimeters, flow meters and environmental chambers to ensure products exceed customer requirements.

· Uses hand tool, soldering tools, and presses to build prototypes and customer evaluations

· Participates and/or leads design reviews and records meeting notes and lessons learned.

· Evaluates and approve design changes, specifications, and drawing releases to ensure compliance with both internal and external specifications and standards.

· Controls drawings, models, and other applicable documents.

· Shall utilize and improve engineering tools with the goal of creating and following consistent processes that ends with a predictable result. Examples of tools include Phase-Gate, FMEA, Control Plans, Engineering Change process, Tolerance Stack-up Calculations, Force Balances, Design for Manufacturing tools, Design Verification Plans, Process Validation, Capability Studies, Measurement System Evaluations, Quality Management and Production Part Approval Processes.

· Support sales staff by providing technical data to present to customers.

· Interface with other departments within and external customers and suppliers.

· Follows policies and procedures according to Quality Management System.

· All other duties as assigned.

Design Engineer

Behavioral

· Must have the potential to advance to Sr Design Engineer

· Proactive on tasks (Completes in a timely manner, uses tools to track task)

· Responsible (demonstrate that others can trust you)

· Demonstrates that he or she can be part of a solution (both technical and behavioral)

· Good verbal and written skills, in both a technical and non-technical environment

Demonstrated Competence:

· Good mechanical aptitude, and working knowledge of different materials (metals, plastics, etc.), coatings/finishes, and hardware.

· Good working knowledge of different manufacturing processes; CNC, injection molding, welding, turning, milling, etc.

· Good working knowledge of spring design

· Ability to support customer meetings and work directly with customers on design-related tasks.

· Ability to work with suppliers as it relates to prototype builds and associated changes and corrections.

· Able to design product(s) with input from others on lessons learned and best practices.

· Tends to work on projects, and not programs involving multiple designs and products.

· Participates in Root Cause analysis, DFMEAs, PFMEAs, Control Plans, Corrective Actions and other Quality activities.

· Understands the Cost of Goods (COGS) and how design impacts the material and manufacturing costs.

· Identifies design constraints and works with internal and external resources to resolve the constraints.

· Understands and utilizes all applicable processes and procedures.

Education and/or Experience:

· Bachelor's Degree (BS) from an accredited college or university in an Engineering related field or acceptable type and amount of work experience in a design role.

· 1-year design experience.

· Basic working knowledge of Microsoft Suite of products with a strong working knowledge of Excel.

· Demonstrated knowledge of SolidWorks or other 3D Modeling software.

· Experience with DFMEA, PFMEA, DOE, and other AIAG procedures preferred.

· Experience with magnetic analyses, computation fluid dynamics and finite element analysis preferred.

A manufacturing company located in Waukesha county is looking for a Quality Manager. This is a great opportunity to lead a team of Quality Techs and Engineers at a company that manufactures precision machined parts for some of the biggest names in the agriculture and heavy equipment industries

Responsibilities/Qualifications:

• MUST HAVE experience with high volume machining
• BS in Engineering or related field preferred
• Quality Certifications preferred (CQE, CQA, etc)
• Experience in metal manufacturing
• Maintain the company’s QMS
• Internal and Supplier auditing
• Familiar with quality measurement tools
• Continuous improvement mindset
• Ability to lead/develop Quality Technician and Engineers

Why join AVIRE?

Do you have an entrepreneurial mindset? Do you like being part of high growth, high impact environments? Are you looking for an opportunity to lead a world class team intent on providing an unrivalled customer experience? If you have answered yes to these questions, we should connect!

The Avire Sussex, WI team is looking for a highly driven, highly motivated individual to take us to new heights. In this role, you will be responsible for planning, coordinating, and deploying the resources necessary to ensure our manufacturing capabilities grow with the organization focusing on continuous improvement--ensuring that our team is supported to effectively build high-quality products for our customers. Our assembly team is critical to our success as an organization as we produce high quality products that surpass customer expectations. You will be a part of a team of dedicated Production, Shipping and Receiving personnel, Supply Chain professionals, Technical Support Specialists, and Operations experts with the collective goal of supplying high quality products with a best-in-class lead-time exceeding our customer’s highest expectations. Further, you will be a part of a team that has a track record of delivering double digit compound growth while supporting each other. This position reports to the Operations Manager.

What you will do:

1. Sets clear, attainable production-level and cell-level production targets and direct the team to meet these objectives.
2. Manage daily production activities for the assembly cells including scheduling, production quality, material shortages and nonconformance reporting.
3. Manage the production employees, including performance management, health and safety, and individual training & development.
4. Work cross-functionally to ensure effective production processes and align resources to meet both customer & business demands.
5. Work directly with product management to ensure sustainable production for critical products while providing guidance to drive design for manufacturing/design for automation improvements. Facilitates new product integration and manages related engineering changes.
6. Build a culture of continuous improvement to ensure effective labor and materials management are engrained in everyday activities. Support continuous improvement initiatives and implement and evaluate outcomes.
7. Work directly with operational leadership to manage production requirements in alignment with business objectives & strategies and prepare monthly production reports.
8. Maintain production standards to ensure accurate labor reporting and costing.
9. Ensure compliance with local standards and maintains a safe working environment.
10. Perform other duties as assigned.

We want someone who displays:

Action-Oriented Curiosity: You readily take on challenges, and you identify and seize new opportunities. You have an outstanding history of delivering on your projects. You work on the problems that truly need solving, and you effectively challenge the organization to be better. You can cut through the clutter and focus on the priorities that align with organizational objectives.

Collaboration: You embrace the unique experiences, viewpoints, and abilities of your teammates and proactively engage those differences to come to the best possible outcome.

Empowerment: You thrive in an environment where you can make decisions. You do not shy away from taking a stand, and you recognize the importance of challenging the team to ensure that we strive for more. You take responsibility to solve customer problems the first time.

Accountability: You take responsibility for your actions, and you deliver on your commitments.

Inclusion: In all aspects of your work, you treat everyone with respect.

Performance Objectives

1. Cells are functioning effectively and team members are deployed in alignment with the needs of the business.
2. Lean principles are implemented and driven throughout the organization.
3. Performance management, including training & development, is process-driven and implemented consistently throughout the manufacturing team.
4. Plan production schedule and allocate resources to drive efficient, timely output, targeting improved productivity.

Job Skills

• Strong interpersonal and communication skills
• Proven problem-solving proficiency
• Proven ability to lead hourly employees in a manufacturing environment
• Experience in electronics manufacturing a plus
• Experience with KPI metric management and deployment
• Excellent written, verbal, and interpersonal skills to work effectively with diverse groups of people both within, and outside, of the organization.

Qualifications

• Bachelor’s degree in engineering, engineering management, supply chain or a related field
• A minimum of 5 years’ experience in a production environment holding positions of progressive responsibility
• Alternative combinations of education and experience will be considered
• A minimum of 3 years’ experience in a direct management position
• Strong interpersonal and communication skills at all organizational levels
• Strong decision-making skills and results-driven approach
• Proven analytical ability and familiarity with a KPI-driven operations environment
• Proficiency in Lean Principles a plus: Problem Solving, 5S, Flow, Standard Work, Kanban

Who is AVIRE?

Connecting and Protecting People. AVIRE combines 4 market-leading brands (Rath, Janus, Microkey, and Memco) within the elevator and emergency communications industries; currently offering light curtains, area of refuge, emergency telephones / GSMs, and life safety solutions. Each brand has a strong market presence, a unique identity, a distinct product range, and a long, successful history. The group has manufacturing locations in 2 countries, R&D in 2 countries and Sales & Marketing in 8 countries employing over 400 people globally.

AVIRE is part of the Halma group ( ). Halma bets on talent! We are looking for bright, ambitious people to join our team and stay for the long term. With over 50 businesses under its ownership, Halma is a great place to start, advance, or accelerate your career.

Benefits

• Competitive salary
• Organizational bonus plan
• Complete benefits package including health, dental & vision insurance, 401K, paid vacation, paid holidays, and generous parental leave
• Professional development training opportunities
• Company events (i.e. bbq’s, lunches, bowling and much more)!
• 4 x 10 hour schedule Monday – Thursday

MANUFACTURING PLANT IN WAUKESHA WI IS LOOKING FOR MANUFACTURING ENGINEERS. LOOKING FOR SOMEONE SHARP WITH CONTINUOUS IMPROVEMENT ENGINEER.

SHIFT: 7AM-330PM

SALARY: $73K-$94K + 5% TARGET BONUS

PTO: YOU GET 2 WEEKS AFTER 90 DAYS (5 PERSONAL/SICK DAYS & 5 DAYS PTO)Manufacturing Engineer

Core Responsibilities

• Develop and optimize manufacturing processes, routings, work instructions, and standard work to meet safety, quality, delivery, and cost targets.
• Lead continuous improvement initiatives focused on OEE, scrap reduction, labor efficiency, throughput, and productivity gains.
• Design and implement tooling, fixtures, automation, and poka-yoke solutions to improve process capability and repeatability.
• Analyze production data to identify bottlenecks and downtime drivers; lead structured root-cause analysis (5 Why, Fishbone, A3) and corrective actions.
• Partner with Quality to develop control plans, PFMEAs, Cp/Cpk studies, and standardized inspection methods.
• Support new product introductions through process development, equipment validation, pilot builds, and launch activities.
• Drive cost-reduction initiatives via cycle time improvements, material yield optimization, and value engineering.
• Collaborate with Operations and Maintenance to improve equipment reliability, preventive maintenance strategies, and uptime.
• Maintain accurate manufacturing documentation including BOMs, routings, standard times, work instructions, and process flow diagrams.
• Evaluate capital equipment needs, build ROI justifications, and manage installation and commissioning.
• Provide hands-on floor support to troubleshoot issues and stabilize daily production.
• Ensure compliance with safety, regulatory, and internal operational standards.

Qualifications

Required:

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, or related Engineering discipline
• 3–7 years of Manufacturing Engineering or process improvement experience
• Strong understanding of process flow development and production optimization
• Experience with structured problem-solving methodologies (5 Why, Fishbone, A3, etc.)
• Proven record of improving productivity, quality, or cost in a manufacturing environment

Preferred:

• Experience in job shop or mixed-model manufacturing
• Familiarity with ERP/MES systems (NetSuite, SAP, Oracle, SmartFactory, etc.)
• Automation, robotics, CNC, or assembly experience
• Lean or Six Sigma certification
• Capital equipment implementation and ROI justification experience

Power Test®, LLC is an industry leader in the design, manufacture, and sale of dynamometers, heavy equipment testing systems and related data acquisition and control systems. For over 40 years, Power Test has provided specialized test equipment to manufacturers, rebuild facilities, and distributors in the mining, oil and gas, power generation, marine, trucking, construction, rail, and military markets in over 90 countries on six continents. Our headquarters and manufacturing operations are located in Sussex, Wisconsin with sales representatives worldwide.

Power Test Lifecycle Services is the aftermarket and services brand of Power Test, focused on maximizing customer uptime through genuine parts, remanufacturing, and lifecycle support. Specifically, Power Test PARTS focuses on serving the company’s customers by ensuring they have the right parts, at the right time, every time.

Position Summary

The Product Manager – Parts & Remanufacturing owns both the Parts and Remanufacturing product lines and is responsible for ensuring profit growth and achievement of revenue and margin targets. This role carries both commercial growth responsibility and operational fulfillment oversight, ensuring revenue expansion, margin performance, inventory discipline, customer responsiveness, and execution excellence. This leader operates at both strategic and tactical levels — defining pricing and growth strategy while ensuring quoting accuracy, order processing discipline, customer service performance, and fulfillment execution. The role ensures the fulfillment model (internal and external) supports customer uptime, availability, and growth initiatives. This position is essential to Power Test’s mission to serve its customers under the company’s dedication to “We Make it Better”.

Commercial Growth & Portfolio Ownership

• Own revenue, profit, and margin growth across Parts & Remanufacturing.
• Lead pricing strategy, margin optimization, and policy governance.
• Utilize sales and ERP data to identify incremental revenue opportunities

Sales Team Leadership & Capability Development

• Lead and manage the Aftermarket Parts Sales Team.
• Evaluate departmental capability gaps and implement structured development plans.
• Lead weekly department meetings focused on performance, backlog, and execution.

Operational Fulfillment Oversight

Deliver world-class performance in safety, quality, fulfillment, productivity, and cost.

• Own end-to-end order lifecycle execution
• Develop and execute the Parts Fulfillment Strategy, including:
• Lead parts stocking initiatives and inventory optimization efforts.

Required Qualifications

• Bachelor’s degree in business, Operations, Engineering, or related field.
• Understanding of capital equipment manufacturing environments.
• Minimum of 5 years’ experience in aftermarket parts, remanufacturing, service operations, or customer-facing commercial roles.
• Demonstrated experience owning commercial growth and operational execution within a product or business line.
• Strong cross-functional communication skills (written and verbal).
• Self-motivated with the ability to adapt in a fast-paced, evolving environment.
• Strong analytical capability with advanced data analysis skills.
• Advanced proficiency in Microsoft Excel (pivot tables, dashboards, financial modeling) at a minimum.
• Proven ability to balance analytical thinking with hands-on problem solving.

Benefits

What Makes Power Test Different?

At Power Test We Make It Better for our Customers, our Community, and our Employees. We provide industry leading products, work vigorously in our community, and encourage a healthy, financially rewarding, work-life balance for our employees.

Notably, Power Test has a broad based employee ownership program: Powered by Ownership. Powered by Ownership provides every employee an equity interest in the company. Powered By Ownership is more than just a benefit, it reflects Power Test’s commitment to building an ownership mindset across the company. Together, the team is strengthening culture, rewarding innovation, and shaping a future where success is shared. This mindset is captured in Power Test’s ownership slogan: Together We Build, Together We Prosper.

Job Title: Manufacturing Supervisor

Location: Waukesha, WI | 100% Onsite

Company: Prolec-GE Waukesha, Inc.

Employment Type: Full-Time 40+ hours | Long term | Permanent

About the Role

Are you passionate about driving operational excellence and leading high-performing teams? As a Manufacturing Supervisor, you will play a critical role in ensuring production goals are met while maintaining the highest standards of quality, safety, and continuous improvement. This is an exciting opportunity to lead a dynamic team, optimize processes, and make a measurable impact on our manufacturing operations.

What You’ll Do

• Lead and Inspire: Supervise and motivate your team to achieve production targets, maintain quality standards, and foster a culture of safety and accountability.
• Drive Operational Excellence: Monitor workflows, troubleshoot production challenges, and implement solutions that enhance efficiency and reduce costs.
• Champion Quality: Ensure compliance with manufacturing procedures and engineering instructions, investigate non-conformance issues, and take corrective action.
• Develop Talent: Participate in hiring, create training plans, and provide coaching and feedback to build strong, skilled teams.
• Promote Continuous Improvement: Identify opportunities for process enhancements and lead initiatives that align with plant goals.
• Ensure Safety & Compliance: Maintain a safe work environment, conduct investigations when necessary, and uphold company and union guidelines.

What We’re Looking For

• Bachelor’s degree with 3–5 years of manufacturing leadership experience (or equivalent leadership experience).
• Strong communication and problem-solving skills.

Preferred Qualifications:

• Degree in Operations Management or Engineering.
• Experience in a unionized environment.
• Background in engineered-product manufacturing.
• Proficiency in Microsoft Office.

Key Skills for Success

• Proven leadership and team-building abilities.
• Excellent interpersonal and communication skills.
• Strong analytical and decision-making capabilities.
• Commitment to safety, quality, and continuous improvement.

Why Join Us?

At Prolec-GE Waukesha, Inc., we value innovation, collaboration, and professional growth. You’ll have the opportunity to lead impactful projects, work with cross-functional teams, and contribute to a company that powers progress. We offer competitive compensation, comprehensive benefits, and a supportive environment where your ideas matter.

Prolec-GE Waukesha, Inc. is an equal opportunity employer and makes employment decisions without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, genetic information, disability, protected veteran status, or any other reason prohibited by applicable law.

Now Hiring: Product Supervisor - High Voltage Testing — Prolec‑GE Waukesha

Location: Waukesha, WI | 100% Onsite | 1st shift | Monday - Friday

Ready to power up your career?

Prolec‑GE Waukesha is seeking a Product Supervisor - High Voltage Testing who thrives at the intersection of people leadership, experience with electrical engineering, high‑voltage safety, and technical decision‑making.

If you’re energized by guiding teams, ensuring strict safety compliance, solving complex electrical problems, and keeping operations running with discipline and precision — this could be your next big opportunity.

What You’ll Do

As our Product Supervisor - High Voltage Testing, you’ll be the leadership anchor in a high‑voltage testing environment where safety and accuracy are everything. Your impact will include:

Safety & Compliance Leadership (Top Priority)

• Enforcing high‑voltage safety rules, lockout/tagout, grounding, and test‑bay controls
• Leading safety briefings, risk assessments, and incident investigations
• Having the confidence and authority to stop work immediately when unsafe conditions arise

Team Leadership & Development

• Supervising a team of highly skilled test technicians
• Coaching, mentoring, and addressing behavioral or procedural deviations
• Building trust, communicating expectations clearly, and fostering a culture of accountability

Technical Oversight & Test Execution

• Overseeing daily test operations to ensure quality, accuracy, and adherence to approved procedures
• Troubleshooting test issues and coordinating closely with Engineering, Quality, and Manufacturing
• Making sound go/no‑go decisions under pressure — without compromising safety or compliance

Operational Excellence

• Maintaining accurate training, attendance, and documentation
• Identifying process gaps and driving improvements that enhance safety, consistency, and efficiency
• Supporting internal/external audits with strong attention to detail and documentation discipline

What You Bring

We’d love to meet you if you’re someone who has:

• A Bachelor’s in Engineering or Operations Management (or relevant experience with strong manufacturing leadership)
• Experience in electrical testing, high‑voltage environments, or an electrical mindset
• A leadership style that is confident, steady, empathetic, and able to hold firm boundaries
• Strong communication skills — able to stay calm, clear, and professional in fast‑paced, high‑risk situations
• A willingness to learn quickly, ask questions, and adapt to technical processes
• Working knowledge of Microsoft Office and comfort navigating manufacturing systems

Bonus advantages for experience with:

Transformers

Switchgear

Power distribution products

Electrical Engineering

Physical & Work Environment

This is a hands‑on, on‑the‑floor leadership role in a high‑voltage test environment. You’ll be:

• Moving throughout the manufacturing area
• Working near energized equipment (with full training & protections)
• Lifting up to 25 lbs as needed
• Splitting time between office tasks and shop‑floor oversight (best of both worlds)

Why Prolec GE Waukesha?

At Prolec‑GE Waukesha, you’ll step into a role where your leadership directly protects people, strengthens reliability, and supports the products that power communities across the country.

You’ll join a team that values collaboration, continuous improvement, and strong technical discipline — and you’ll grow your own leadership capability in the process.

Ready to energize your career?

Apply now and help shape the future of power transformation!

Prolec-GE Waukesha, Inc. is an equal opportunity employer and makes employment decisions without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, genetic information, disability, protected veteran status, or any other reason prohibited by applicable law.

About the Company

MRPC is an Affirmative Action Equal Opportunity Employer: Minorities, Women, Veterans, & Disabilities.

About the Role

Under the general supervision of the Director of Manufacturing or Production Manager, the Production Supervisor is responsible for supervising the production team and scheduling shift production activities. This individual will also provide hands on assistance with machine set-ups.

Responsibilities

• Schedule and assign work to production personnel, to support production schedule and priorities.
• Supply stock/supplies to the production areas as required.
• Maintain the required shift reports to include machine counts, rejection rates, and labor reports.
• Ensure that all personnel are properly trained in the job functions associated with specific work assignments including manufacturing procedures, quality requirements and proper use of all tools.
• Follow established ISO and production procedures, ensure that all production employees are properly trained and are following procedures. Recommend changes to the procedures that will improve quality and/or productivity.
• Make hire, discipline and promotion recommendations of subordinates. Prepare annual written performance reviews and establish annual objectives consistent with the overall business strategy.
• Ensure the maintenance of general housekeeping for the department.
• Coordinate tool repairs/modifications with tool room and engineering.
• Perform all activities required to operate equipment, adjusting machinery to meet operating parameters specified.
• Following specifications, determine the appropriate methods of equipment operation. May operate several presses simultaneously.
• Perform new job or mold sampling when necessary, working with engineering.
• Perform other duties as assigned.

Qualifications

• High School Diploma or GED
• Injection molding experience
• Demonstrated leadership, project management, facilitation and problem-solving
• Strong interpersonal and communication skills
• Ability to manage multiple priorities
• Strong team player

Required Skills

• Injection molding experience
• Demonstrated leadership, project management, facilitation and problem-solving
• Strong interpersonal and communication skills
• Ability to manage multiple priorities
• Strong team player

Preferred Skills

• None specified

Pay range and compensation package

Not specified

Equal Opportunity Statement

MRPC is an Affirmative Action Equal Opportunity Employer: Minorities, Women, Veterans, & Disabilities.

Quality Engineer

As a Quality Engineer, you will assist with the development of quality systems, procedures and controls to ensure that all medical products consistently meet performance and quality specifications in the Germantown Manufacturing facility. The Quality Engineer is a leader and strong technical resource who quickly and effectively resolves quality problems with internal and external customers and suppliers.

Below Are Additional Duties And Responsibilities

• Generates, communicates, and implements ideas and solutions.
• Demonstrates accuracy and thoroughness in completing tasks timely.
• Looks for ways to improve and promote quality.
• Monitor Corrective Action System (i.e. Customer Complaints, Supplier, Internal)
• Initiate and investigate Customer Complaints according to our internal procedure and standards.
• Record essential information on internal and/or customer-specific documentation, including updating customer portals.
• Perform investigations using Lean, Six Sigma, and statistical methods to support root cause analysis and corrective actions.
• Identify gaps and/or trends in systems or processes.
• Initiate and facilitate the Corrective/Preventative Action process using the appropriate quality tools and input from subject matter experts (SME) to implement sustainable solutions.
• Update Quality documents according to our Change Control procedures, as required.
• Verify corrective action effectiveness.
• Drive Non-Conformance Process
• Evaluate and investigate suspect non-conforming product identified by manufacturing and/or the Quality Lab.
• Initiate containment activities, as necessary, with Customer Service and Shipping Department.
• Recommend disposition of product based on thorough investigation and data-driven feedback.
• Initiate and assist Customer Service with Return Material Authorization (RMA) process.
• Develop re-inspection, sort, and/or rework instructions for Manufacturing Operators, as required.
• Collaborate with customer on issuing waiver or deviation documentation and obtain customer approval, as required.
• Maintain the Quality Management System (QMS).
• Understand ISO 13485 Quality management systems requirements.
• Ensure continuing compliance to both internal processes as well as requirements imposed by certification bodies, regulatory agencies, and specific customer requirements.
• Assist in internal, 2nd party, and 3rd party audits.
• Assist with responses and corrective actions for audit findings.
• Support Product Realization process
• Participate in design review, process planning, and failure mode analysis
• Provide input on evaluation of Key Product Characteristics.
• Provide input on gaging methods and equipment.
• Interpret customer requirements including complex blueprints and GD&T call-outs.
• Review and approve Engineering Change Notifications and Verifications
• Evaluate for feasibility and implement updates to customer requirements into associated product control plans, pFMEA, Inspection documentation and other related documents.
• Incorporate industry standard best practices.
• Incorporate lessons learned.
• Evaluate, submit and track Supplier Change Notices to customers and/or suppliers.
• Any other duties as assigned.
• Manufacturing point of contact for the review and disposition of product quality related questions.
• Approve Medical Device release for shipment, as required.
• Perform batch record reviews for medical device prior to release for shipment.
• Generate Certificate of Analysis, as required.
• Release product in ERP system based on customer and process requirements.
• Support Manufacturing process
• Train Manufacturing and Quality Control personnel on customer requirements, inspection techniques, lessons learned, and rework instructions.
• Manage product inspection and testing activities.
• Obtain customer approvals for all required changes based on Quality Agreements.
• Compile supporting measurement and process performance data, as necessary
• Assemble supporting documentation package and review for completeness and accuracy
• Review and approve production documentation updates according to our Engineering Change Order process.