1

Contract Capa Engineer Jobs in Wisconsin (NOW HIRING)

Showing results 41-45

Contract Capa Engineer information

What is a contract CAPA engineer?

A Contract CAPA Engineer is a professional hired on a temporary or project basis to manage and oversee Corrective and Preventive Action (CAPA) processes within an organization, typically in regulated industries such as pharmaceuticals, medical devices, or manufacturing. Their primary responsibility is to investigate issues, identify root causes, and implement solutions to prevent recurrence of non-conformities. They ensure that CAPA processes meet regulatory standards and help maintain compliance with industry guidelines. Contract CAPA Engineers often work with cross-functional teams to drive continuous improvement and ensure product quality.

What are the key skills and qualifications needed to thrive as a contract CAPA engineer?

To excel as a Contract CAPA Engineer, you need a strong background in quality engineering, root cause analysis, and regulatory compliance, often supported by a degree in engineering or a related field. Expertise in CAPA management systems, quality management software (like TrackWise), and knowledge of ISO 13485 or FDA regulations are typically required. Strong analytical thinking, attention to detail, and effective communication skills help drive successful corrective and preventive actions. These competencies ensure regulatory compliance, minimize risks, and maintain product quality in regulated industries.

What are some common challenges faced by a contract CAPA engineer when implementing corrective and preventive actions across multiple client sites?

As a Contract CAPA Engineer, one of the main challenges is adapting to different organizational processes and quality management systems at each client site. Each company may have unique documentation standards, regulatory requirements, and communication protocols, which can complicate the investigation and resolution of quality issues. Balancing multiple projects, aligning stakeholders, and ensuring timely closure of CAPA actions while strictly adhering to compliance standards requires strong organizational and interpersonal skills. Successful engineers proactively build rapport with client teams and remain detail-oriented to ensure all corrective and preventive actions are both effective and audit-ready.

What is the difference between Contract Capa Engineer vs Contract Failure Analysis Engineer?

AspectContract Capa EngineerContract Failure Analysis Engineer
Required CredentialsBachelor's in Engineering, Six Sigma, Root Cause AnalysisBachelor's in Engineering, Six Sigma, Root Cause Analysis
Work EnvironmentManufacturing, Aerospace, AutomotiveManufacturing, Aerospace, Automotive
Employer & Industry UsageQuality departments, Reliability teamsQuality departments, Reliability teams
Common Search & ComparisonYesYes

Both roles focus on quality and reliability, requiring similar certifications and working in manufacturing or aerospace industries. The Contract Capa Engineer primarily manages corrective and preventive actions to address issues, while the Contract Failure Analysis Engineer investigates root causes of failures. They often collaborate but serve distinct functions within quality assurance teams.

What are the most commonly searched types of Capa Engineer jobs in Wisconsin?

The most popular types of Capa Engineer jobs in Wisconsin are:

What job categories do people searching Contract Capa Engineer jobs in Wisconsin look for?

The top searched job categories for Contract Capa Engineer jobs in Wisconsin are:

$180K - $200K/yr

Full-time

Posted 6 days ago


Job description

Description:Director of Operations
Job Type

Full-time, Exempt

Location: Butler, WI

All candidates must take a culture index at https://go.cultureindex.com/p/avmIbPbYK23sNl87WrcV to be considered for the position.

WHY MRPC?

In a nutshell, our products improve the lives of people throughout the globe. Perhaps even you OR someone you know. From state-of-the-art robotic surgeries to cutting edge treatments for Parkinson’s patients. MRPC is a leading contract manufacturer of highly engineered molded components and complex assemblies serving the medical device and life sciences industries. MRPC partners with many of the world’s most recognized OEMs to deliver mission-critical products that demand precision, cleanliness, and performance reliability in regulated applications.

We are in a phase of unmatched expansion, investing heavily in our people, processes, technology, and facilities. Our growth plans are bold, deliberate, and real. This is a place where leaders are empowered, technical excellence is expected, and great ideas turn into action.

In search of a purpose? Join our TEAM!


POSITION SUMMARY:

Primary responsibility is overseeing manufacturing profitability for multiple plants with multi-shift environments, ensuring materials, equipment, and labor resources are allocated per operating plans and systems are implemented for teams to effectively and efficiently execute the day-to-day operations.

Policy Deployment that aligns with corporate strategies for “Growth”, “Foundational”, and “Continual Improvement” categories. Provide guidance and support for the operations teams to achieve Key Performance Indicators (KPIs) and individual and collective goals. This includes assessing individual job performance, developing training programs, and setting targets for improvement.

Requires excellent communication and analytical skills, as well as a deep understanding of manufacturing processes and technology. The Director of Operations works closely with other departments in the company including but not limited to: Human Resources, Quality Assurance, Engineering and New Product Development teams, Finance, Supply Chain, Sales, and Account Management.

ESSENTIAL DUTIES & RESPONSIBILITIES:

This list of duties and responsibilities is not all inclusive and may be expanded as management determines necessary.

Leadership & Training:

· Responsible for the facilities and manufacturing teams and an escalation point to the executive team.

· Recruit, hire, and develop teams and ensure management system procedures are deployed, with assessment of training effectiveness.

· Deploys a versatility matrix approach using Training Within Industry (TWI) methods to ensure depth and competency of skills and certifications.

· Allocates resources to keep up with unplanned and planned maintenance requirements and utilizes a TPM (Total Productive Maintenance) approach for the production team to conduct minor maintenance.

An advocate for a culture of Safety-Quality-Delivery-Cost (SQDC) in all manufacturing areas and be well versed in these aspects for management review inputs and outputs.

Safety: “safe work and safe products”

· “Safety First - Zero Incident” mindset where all incidents can be prevented to achieve “safe work, safe products”.

· Interpret company policies and ensure plant safety rules and practices and endorsed by plant leadership to include timely incident investigations to prevent an occurrence.

Quality: “do not accept, make, or pass on defects”

· Lead with a mindset to “not accept, make, or pass on defects” and bolster operational controls which reduce the Cost of Poor Quality.

· Develop a manufacturing team that has problem solving & troubleshooting skills to promptly determine causes of defects and implement countermeasures to prevent poor quality.

· Allocate resource responsibilities for suspect products and a Material Review Board (MRB) process.

· Support a robust corrective and preventive action (CAPA) which prevents recurrence and considers a read across to similar processes or products.

· Ensure that all production and support employees are properly trained and following the management system procedures and support FDA and ISO 13485 compliance. Recommend documentation changes which could improve the management system.

· Work with teams to review historical performance and select and drive team projects which reduce scrap.

Delivery: “on-time in-full”

· Seek “on-time in-full and reduced lead times” for the product realization process.

· Provide resources to support production priorities in which key customers’ requirements have heavier weighting.

· Provide input to planning and scheduling for best performance and to mitigate constraints using “runs best” or “alternate” work centers and seeking flexibility by working with QA to qualify multiple work centers.

· Assist with solutions which mitigate supply chain and outsourced processes constraints.

Cost: “productivity, inventory control, remove waste”

· Cross-functionally seek “productivity, inventory control, and waste removal”.

· Manage plant to P&L and financial plan expectations; adjust manufacturing plans to meet product sales and control associated costs and assist in the oversight of costs of support processes.

· Review Bills of Manufacture (BOM) for the manufacturing inputs to ensure the standards reasonably reflect intended costs of material, labor and overhead.

· Identify opportunities and implement projects which support Lean with a 5S and removal of the 8 Types of Waste and focus on improving the value-adding activity.

· Understand the components of Overall Equipment Effectiveness (OEE) measures and seek improvement or implement countermeasures to the six big losses in real time or with data sets.

QUALIFICATIONS (KNOWLEDGE, SKILLS & ABILITIES):

· BS Degree in Technical Discipline and/or 10+ years of molding or a related process of making components

· Demonstrates leadership and execution, with project management, facilitation and team building

· Understanding of ISO13485, FDA 21 CFR 820 and cGMP requirements and medical or food grade manufacturing with clean rooms

· Strong team player and demonstrated leadership qualities using interpersonal skills to manage multiple priorities

· Proficiency with Microsoft 365 and ERP with MES elements

· Previous experience implementing improvements using continuous improvement and problem-solving techniques, such as Lean / Six Sigma Manufacturing, drive productivity improvements.

· Understanding of budgeting/expense management with a basic understanding of financial information.

· Solid presentation, verbal and written communication skills and comfortable interacting with all levels of the core organization, and with customers and vendors.

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


#MRPCJOBS

Requirements: