Capa Manager Jobs in Michigan (NOW HIRING)

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

 Provides advanced technical expertise and independent execution of supplier quality engineering activities supporting product development, manufacturing, supplier management, and continuous improvement initiatives. Serves as a key contributor on cross-functional teams, driving effective resolution of supplier quality issues while ensuring compliance with quality system and regulatory requirements.

Job Responsibilities and Essential Duties

• Independently manage supplier quality activities for assigned suppliers, commodities, and manufacturing processes while supporting the overall Supplier Quality Assurance function for the SWICC organization.
• Provide site leadership for Supplier Management, which includes maintaining supplier corrective actions, supplier audits, supplier certification, non-conforming material review, and supporting incoming material inspection.
• Lead supplier qualification activities, including First Article Inspections (FAI), component qualifications, process validations, and supplier change evaluations.
• Develop, review, and update supplied component sampling plans based on associated risk and past performance.
• Develop standard inspection procedures, work instructions, quality test methods, and policies related to supplier controls and supplier management.
• Act as a primary liaison between the company and suppliers, ensuring effective communication, alignment of quality expectations, and timely resolution of supplier-related quality and compliance issues.
• Drive supplier quality improvement initiatives through collaborative engagement, performance monitoring, and implementation of effective corrective and preventive actions.
• Lead complex supplier quality investigations utilizing root cause analysis, statistical techniques, and structured problem-solving methodologies to identify and implement effective corrective actions.
• Develop and/or maintain Quality Systems to include identifying, initiating, and/or performing Corrective and Preventive Action (CAPA) activities as required under the CAPA system.
• Leads risk management teams that utilize common risk management tools such as FMEA, Hazard Analysis, Risk Assessments, and Quality Plans.
• Collaborate with Engineering, Operations, and Quality teams to ensure component specifications, inspection methods, and quality requirements are clearly defined and effectively communicated to suppliers.
• Review and approve component specifications and other change control-related documentation, including Change Requests (CRs).
• Provides leadership and/or performs Test Method Validation (TMV) and Measurement Systems Analysis (MSA) activities on existing and newly developed test methods.
• Supports the Material Review Board (MRB) by providing or reviewing the disposition of non-conforming material.
• Support GetQMS Supplier Quality initiatives for SWICC.
• Actively identifies, pursues, and champions improved strategies for assuring excellent quality through the use of SPC, non-destructive testing, cost-effective sampling plans, quantitative measures, and other quality engineering tools.
• Develop, maintain, and communicate supplier quality performance metrics, trends, and improvement opportunities to management and cross-functional stakeholders.
• Monitors progress using financial and operational metrics.
• Represent the company during regulatory agency inspections, notified body audits, customer audits, and other third-party assessments by providing technical expertise and supplier quality support.

Minimum Requirements

• Bachelor's degree in Engineering and 5 years' experience or Associate's degree with seven years industry experience.
• Proficiency in MS Office applications (Word/Excel) is required.

Required Knowledge, Skills and Abilities

• Strong verbal and written communication skills are required.
• Basic knowledge in the areas of lot acceptance, sampling methodologies, MSA/GR&R, CAPA, root cause analysis, and other statistical techniques.
• Audit experience is required.

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments
• May work extended hours during peak business cycles
• Physical requirements such as lifting
• Some travel required

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodation may be made to enable individuals with isabilities to perform the essential functions.

Monday-Friday, 8:30am-5pm

Salary Range:  $96,240 - $120,300/annually + 5% STIP

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About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.