ZipRecruiter

Log In

1

Contract Capa Engineer Jobs in Washington (NOW HIRING)

next page

Showing results 1-20

People also search for

All JobsContract Capa Engineer JobsContract Capa Engineer Jobs in Washington

Contract Capa Engineer information

What are the key skills and qualifications needed to thrive as a Contract CAPA Engineer, and why are they important?

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 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 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 popular job titles related to Contract Capa Engineer jobs in Washington? For Contract Capa Engineer jobs in Washington, the most frequently searched job titles are:
What job categories do people searching Contract Capa Engineer jobs in Washington look for? The top searched job categories for Contract Capa Engineer jobs in Washington are:
What cities in Washington are hiring for Contract Capa Engineer jobs? Cities in Washington with the most Contract Capa Engineer job openings:
Contract Capa Engineer jobs near you
Global Supplier Quality Engineer II

Global Supplier Quality Engineer II

Integra LifeSciences

Columbia, MD • On-site

$71.30K - $97.75K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 5 days ago

Integra LifeSciences rating

9.3

Company rating: 9.3 out of 10

Based on 7 frontline employees who took The Breakroom Quiz

Job description

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY

The Global Supplier Quality Engineer II will play a vital role supporting Supplier Quality by conducting supplier audits, and maintain supplier quality requirements for Integra's manufacturing site in Columbia, MD. This individual will provide quality assurance leadership to select contract manufacturing sites and raw material suppliers engaged in the production of Integra products.

JOB DESCRIPTION

  • Establishes and ensures the Approved Supplier List is up to date

  • Establishes timely planning and execution of supplier audits

  • Conducts Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements

  • Ensures comprehensive measurement systems in place to monitor supplier quality/reliability, and to identify, correct and prevent defects

  • Establish and ensure Supplier Quality Agreements are up to date for applicable suppliers engaged in the production of Integra products

  • Ensure technical support to QC, purchasing and production departments

  • Provide Quality Engineering Support to suppliers including audits/assessments, inspection technique support, verification /validation activities, CAPA and change management. FDA CFR part 820 and ISO 13485 regulations/standards will be the focus.

  • Addresses Supplier Change Requests in compliance with procedures and regulatory requirements.

  • Ensures that activities for validation of outsourced processes/products are performed and documented according to procedures and within the defined timeline.

  • Ensures that Supplier Non-conformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements.

  • Escalate supplier quality issues to management as appropriate, develop and propose robust and compliant solutions.

  • Participates in and leads continuous improvement projects and initiatives.

  • Participates and supports internal and third-party audits / inspections.

  • Manages or participates in quality projects as required.

  • Provides support with complaint investigations as required.

  • Leads quarterly Supplier Management Meetings for the Columbia site

QUALIFICATIONS

  • Bachelor's or master's degree in manufacturing engineering, mechanical engineering, industrial engineering or sciences or a related discipline is required.

  • Minimum 3 years of experience in quality or manufacturing.

  • Medical Device or Pharmaceutical experience is required.

  • Experience or knowledge of ISO 9001 and ISO 13485, 21 CFR 820, requirements preferred.

  • Travel up to 25% with a possibility of international travel.

  • Experience in FDA and other regulatory controlled environment.

  • Strong collaboration skills and experience working in a matrix environment.

  • Ability to read and understand technical and statistical documents.

  • Ability to interface with technical and non-technical personnel.

  • Knowledge of current Good Manufacturing Practices (cGMP) and other applicable standards.

  • Experience using analytical tools to drive data-based decision making.

for the Integra Columbia site. In addition, the position will require support for external and regulatory audits.

Salary Pay Range:

$71,300.00 - $97,750.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law | EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

Integra - Employer Branding from Integra LifeSciences on Vimeo

Apply