Are you an experienced quality control professional with a passion for ensuring the highest standards in medical device manufacturing? We are seeking a Senior Quality Control Manager (Medical Device) in Pittsburgh, PA, to lead and manage all aspects of quality control in a fast-paced medical device manufacturing environment. This role demands a strategic thinker with hands-on experience in developing and implementing robust quality assurance systems, ensuring compliance with FDA regulations, and driving continuous improvement. If you are ready to make a significant impact in the medical device industry, this is your opportunity.
About This Role
The Senior Quality Control Manager (Medical Device) in Pittsburgh, PA, is a critical role responsible for overseeing the development, implementation, and maintenance of quality control systems in a medical device manufacturing environment. This individual will lead a team of quality control professionals to ensure that all products meet the highest standards of quality and safety, as well as comply with regulatory requirements. The role involves conducting inspections, audits, and tests while managing the resolution of any quality-related issues. This position provides an opportunity to work closely with cross-functional teams to enhance quality processes, streamline operations, and improve overall product quality within the medical device sector.
Key Responsibilities – Senior Quality Control Manager (Medical Device) in Pittsburgh, PA
Develop and Implement Quality Control Systems
- Establish and maintain robust quality control systems to meet regulatory and industry standards.
- Ensure all medical device products undergo comprehensive quality inspections before release.
- Regularly review and update quality control procedures to maintain compliance with FDA regulations.
Lead Quality Control Team
- Supervise and mentor a team of quality control professionals to ensure optimal performance.
- Provide training and development opportunities to enhance team members’ skills.
- Foster a culture of accountability and excellence within the quality control team.
Conduct Product Inspections and Testing
- Oversee product inspections to ensure conformity to specifications and regulatory requirements.
- Perform tests and evaluations on materials, components, and final products.
- Implement corrective actions when deviations from quality standards are identified.
Ensure Compliance with Regulatory Requirements
- Stay updated on FDA, ISO, and other regulatory bodies’ requirements to ensure ongoing compliance.
- Prepare for and support regulatory audits and inspections.
- Implement necessary changes to quality control systems based on evolving regulations.
Drive Continuous Improvement Initiatives
- Analyze quality metrics to identify areas for process improvement.
- Lead efforts to streamline operations and reduce quality issues, defects, and waste.
- Implement root cause analysis and corrective action plans for non-conforming products.
Collaborate with Cross-Functional Teams
- Work closely with production, R&D, and engineering teams to resolve quality-related issues.
- Provide expertise to help improve product design and manufacturing processes.
- Ensure effective communication and collaboration between the quality control department and other key stakeholders.
Monitor and Report on Quality Metrics
- Track and report on key quality performance indicators (KPIs).
- Provide regular updates to senior management on the status of quality control efforts.
- Develop and deliver reports on product quality, trends, and improvement initiatives.
Manage Corrective and Preventative Actions (CAPA)
- Lead the investigation and resolution of quality issues identified during inspections or audits.
- Develop and implement CAPA plans to prevent recurrence of issues.
- Monitor the effectiveness of CAPA actions and make necessary adjustments to processes.
What The Client is Looking For in You
The ideal candidate for the Senior Quality Control Manager (Medical Device) in Pittsburgh, PA will possess a combination of technical expertise, leadership abilities, and a deep understanding of quality control in a medical device manufacturing environment. The client is looking for:
- Proven Experience in Quality Control – At least 5-7 years of hands-on experience in quality control within the medical device or similar regulated industry, with a strong understanding of FDA regulations, ISO standards, and industry best practices.
- Leadership Skills – Experience managing a team of quality control professionals, with the ability to inspire, mentor, and drive performance.
- Strong Analytical Skills – The ability to analyze data, identify trends, and solve complex quality issues with root cause analysis and corrective actions.
- In-depth Knowledge of Regulatory Standards – A solid understanding of regulatory requirements such as FDA, ISO 13485, and other relevant standards.
- Process Improvement Mindset – A track record of driving continuous improvement initiatives, focusing on operational efficiency, cost reduction, and improving product quality.
- Attention to Detail – Meticulous attention to detail when conducting inspections, audits, and reviewing documentation to ensure compliance with established quality standards.
Why This Opportunity Stands Out
This role offers a unique opportunity for the right candidate to play a pivotal role in shaping the quality control processes of a growing medical device company. As the Senior Quality Control Manager (Medical Device) in Pittsburgh, PA, you will:
- Work in a High-Impact Role – Your work will directly impact the safety and efficacy of medical devices used to improve patients’ lives.
- Leadership Opportunities – Lead and mentor a dynamic team, contributing to the professional development of your colleagues.
- Competitive Compensation – A competitive salary along with a comprehensive benefits package, including health insurance, retirement plans, and more.
- Collaborative Work Environment – Work with cross-functional teams and senior leadership to drive continuous improvements and deliver results.
- Growth Potential – This is a growing company with potential for future career advancement as the business expands.
FAQs About the Role
Q: What industries should I have experience in?
A: The ideal candidate should have direct experience in quality control in the medical device industry, but experience in other highly regulated sectors such as pharmaceuticals or aerospace may also be considered.
Q: Is relocation required for this position?
A: Yes, the role is based in Pittsburgh, PA. Candidates must either be local or open to relocation. A relocation package may be available for the right candidate.
Q: What is the reporting structure for this role?
A: The Senior Quality Control Manager (Medical Device) in Pittsburgh, PA will report directly to the Quality Assurance Director or similar senior leadership role, and work closely with cross-functional teams.
Q: What is the expected travel requirement for this role?
A: Travel may be required occasionally for supplier visits, audits, or conferences, but the majority of the role’s responsibilities will be office-based in Pittsburgh, PA.
Q: What qualifications and skills are required?
A: A bachelor’s degree in a relevant field (e.g., Engineering, Life Sciences, or Quality Assurance) is required. Certification in quality control or Six Sigma is a plus, as well as at least 5 years of relevant experience in a regulated environment.
Q: How does this role contribute to the company’s success?
A: As the Senior Quality Control Manager (Medical Device), you will ensure that the company’s products meet the highest safety and quality standards, contributing to the company’s reputation, compliance, and market success.
Q: What is the timeline for hiring and onboarding?
A: The company aims to fill this role within the next 30-60 days. Onboarding will involve training on company-specific processes, systems, and collaboration with cross-functional teams to get up to speed.
What Remuneration Can You Expect from This Job?
As the Senior Quality Control Manager (Medical Device) in Pittsburgh, PA, you can expect a highly competitive compensation package that reflects the significance of your role in ensuring product quality and compliance. The base salary for this position ranges from $90,000 to $120,000 per year, depending on your experience, expertise, and industry background. This salary is accompanied by a range of performance-based incentives, offering additional earning potential based on key quality metrics and team performance.
In addition to the base salary, the position offers a comprehensive benefits package, including:
- Healthcare Coverage – Including medical, dental, and vision insurance.
- Retirement Plan – A 401(k) plan with company matching to help you plan for your future.
- Paid Time Off (PTO) – Generous vacation days, holidays, and sick leave to support work-life balance.
- Bonuses – Eligibility for annual bonuses based on company performance and individual contribution to quality control objectives.
- Professional Development – Opportunities for training, certifications, and industry conferences to continue your professional growth.
Overall, this role provides a competitive financial package while offering significant career growth opportunities within a fast-growing and impactful company in the medical device sector.
How to Apply for This Senior Quality Control Manager (Medical Device) Position in Pittsburgh, PA
If you are a highly skilled professional with substantial experience in quality control within the medical device industry and are eager to take on a leadership role, we invite you to apply for the Senior Quality Control Manager (Medical Device) in Pittsburgh, PA. This is a fantastic opportunity to lead quality control initiatives that directly impact product safety, compliance, and overall quality standards in the medical device sector.
To apply, please submit your updated resume along with a detailed cover letter. Your cover letter should highlight your expertise in quality control processes, regulatory compliance (including FDA and ISO standards), and leadership experience in the medical device or similarly regulated industries. We are looking for someone who can demonstrate proven success in implementing quality systems, managing cross-functional teams, and ensuring adherence to industry regulations.
By joining this dynamic team, you will be at the forefront of advancing quality standards, ensuring that products are safe for patient use, and contributing to the continuous improvement efforts within the company. This position offers not just a leadership role, but a chance to drive significant change and improve the medical device industry’s overall product quality.
Apply today to take the next step in your career, where you can make a lasting impact on both the business and the health and safety of consumers.
For more information or to explore similar opportunities, visit our Medical Device Recruiters page.
Tags: Senior Quality Control Manager | Medical Device Quality | Regulatory Compliance | Quality Control | Pittsburgh, PA Jobs
