- Quality assurance support in the design and development support of medical device products, facilitating the application of design/change controls, risk management, quality plan, and implementation of design and development plan including verification and validation activities.
- Oversight of quality inspections for incoming materials, in-process production, and finished medical devices.
- Develop and implement quality assurance procedures and processes for compliance with ISO 13485, CGMP, FDA (21 CFR, 21 CFR part 803, 21 CFR part 806) regulations, MDSAP, EU MDR.
- Analyze data to identify trends and areas for improvement.
- Investigate root cause analysis, nonconformances, and complaints
- Collaborate with cross-functional teams to address quality issues and implement corrective and preventative actions.
- Conduct internal audits to ensure proper compliance with procedures in accordance with regulations and standards.
- Participate in external audits conducted for certification and assist with regulatory inspections (domestic or foreign) or audits conducted by customers, notified body.
- Contribute in design/change control and risk management activities.
- Provide guidance and support to manufacturing teams regarding quality control measures.
- Develop and maintain documentation related to quality processes, procedures, and specifications.
- Assist with project management activities related to quality improvement initiatives.
- Strong knowledge of quality inspection techniques and methodologies.
- Works well under pressure and can honor deadlines.
- Proficient in quality system management principles and practices.
- Ability to analyze data using statistical tools and techniques.
- Knowledge of ISO 13485, CGMP, FDA (21 CFR Part 820, 21 CFR part 803, 21 CFR part 806) regulations, MDSAP, and the interrelation of QMS with EU MDR.
- Experience conducting quality audits.
- Excellent problem-solving skills with the ability to identify the root causes of issues.
- Strong attention to detail and accuracy.
- Effective communication skills, both verbal and written.
- Ability to work collaboratively in a cross-functional team environment.
- Proficiency in Microsoft Office products.
- Salary based on experience
- 401(k)
- 11 Paid Holidays
- Paid Time Off
- Health, Dental and Vision Insurance
- Bachelor of Science in Quality discipline or related science or data science degree
- CQE is a strong plus or other quality certification (CQI, CQM, CQA, CQT, etc.)
- 3-5 Years Minimal Experience
- Experience with ISO 13485, ISO 14971, GDP, CGMP, FDA (21 CFR 820, 21 CFR part 803, 21 CFR part 806) regulations, MDSAP
-
Quality Assurance Manager
2 days ago
Anodyne Surgical O'Fallon, United StatesJob Description · Job DescriptionOverview · Anodyne Surgical is seeking a skilled and detail-oriented Quality Assurance Manager to join our team. As a Quality Manager, you will play a crucial role in ensuring the quality and compliance of our medical devices. You will be responsi ...
-
Clinical Pharmacist Specialist
1 week ago
BJC HealthCare O'Fallon, United States Full timeAdditional Information About the Role · Are you looking for an opportunity to directly impact patient care? As a Clinical Pharmacist Specialist, you will provide pharmaceutical services to patients through daily rounds with a multidisciplinary medical team. Advance your clinical ...
-
Assurance Manager
2 weeks ago
Honkamp Krueger St Louis, United StatesAre you looking for a career in auditing that defies all stereotypes? That balances your love of numbers with opportunities to build relationships and grow in your career? Consider joining Honkamp, P.C.'s fast-growing, team-oriented assurance group. · As part of the assurance te ...
-
Roadway Project Manager
6 days ago
GBA Companies O'Fallon, United States**Position**: Roadway Project Manager - GBA · **Location**: O'Fallon, IL · **Roadway Project Manager - O'Fallon, IL** · **Responsibilities**: · - Manage and/or lead Design on transportation engineering projects including expansion, reconstruction or rehabilitation of intersection ...
-
Assurance Manager
2 weeks ago
Honkamp Krueger & Co., P.C. Saint Louis, United StatesJob Description · Job DescriptionAre you looking for a career in auditing that defies all stereotypes? That balances your love of numbers with opportunities to build relationships and grow in your career? Consider joining Honkamp, P.C.'s fast-growing, team-oriented assurance grou ...
-
Quality Assurance Manager
3 weeks ago
Synectics Chesterfield, United States5 days ago · Be among the first 25 applicants · You will be a proactive partner with the external supply business lines, clinical product development teams, maximizing the contribution of Global Quality Operations with our external contract vendors. · You will be the Vendor Poin ...
-
Quality Assurance Manager
1 week ago
Deutsche Precision, LLC Earth City, United StatesEssential Job Functions: include the following. Other duties may be assigned.Plans and conducts the analysis, inspection, design, tests, and/or integration to assure the quality of assigned product or component.Applies statistical process control (SPC) methods for analyzing data ...
-
Quality Assurance Manager
6 days ago
Deutsche Precision, LLC Earth City, United StatesEssential Job Functions: include the following. Other duties may be assigned. Plans and conducts the analysis, inspection, design, tests, and/or integration to assure the quality of assigned product or component. · Applies statistical process control (SPC) methods for analyzing ...
-
Quality Assurance Manager
3 weeks ago
LanceSoft Chesterfield, United StatesJob Description: Repost Please DO NOT submit previously actioned candidates, they will automatically be disqualified) You will be a proactive partner with the external supply business lines, clinical product development teams, maximizing the contribution of Global Quality Operati ...
-
Quality Assurance Manager
3 weeks ago
LanceSoft Chesterfield, United StatesJob Description: Repost Please DO NOT submit previously actioned candidates, they will automatically be disqualified) · You will be a proactive partner with the external supply business lines, clinical product development teams, maximizing the contribution of Global Quality Oper ...
-
Quality Assurance Manager
3 weeks ago
Synectics Chesterfield, United StatesJob Description · You will be a proactive partner with the external supply business lines, clinical product development teams, maximizing the contribution of Global Quality Operations with our external contract vendors. · You will be the Vendor Point of Contact responsible for t ...
-
Audit and Assurance Manager
3 weeks ago
Prestige Staffing Chesterfield, United StatesJob Description · Job DescriptionJobID: 45015The Human Resources Department of one of the fastest-growing accounting firms in the country is seeking a Technical Trainer who possesses a strong technical skillset, is excited to collaborate and is passionate about delivering outstan ...
-
Quality Assurance Manager
1 week ago
Deutsche Precision, LLC Earth City, United StatesJob Description · Job DescriptionEssential Job Functions: include the following. Other duties may be assigned. · Plans and conducts the analysis, inspection, design, tests, and/or integration to assure the quality of assigned product or component. · Applies statistical process co ...
-
Quality Assurance Manager
3 weeks ago
Parsons Corporation Saint Louis, United States Full timeIn a world of possibilities, pursue one with endless opportunities. Imagine Next · When it comes to what you want in your career, if you can imagine it, you can do it at Parsons. Imagine a career working with intelligent, diverse people sharing a common quest. Imagine a workplace ...
-
Quality Assurance Manager
3 weeks ago
Vectrus (V2X) St Louis, United StatesOverview · The Quality Assurance Manager position is responsible for the overall management and implementation of internal quality and serve as the central point of contact for quality matters. · Location: St. Louis, MO · Responsibilities · * Oversee the activity of the quality a ...
-
Quality Assurance Manager
3 weeks ago
Integrated Intel Solutions St Louis, United StatesJob Description · Job Description · SFA Position 15: Quality Assurance Manager Skill Level 3 (NGA-STL) · Duties include: · Oversee the activity of the quality assurance deliverables · Develop, implement and maintain a system of quality and reliability testing · Provides develop ...
-
Quality Assurance Manager
1 week ago
IC-CAP, LLC St Louis, United StatesThis is a future position that may come open but is not open at the present moment. We are willing to prescreen personnel for these positions if you are interested. Quality Assurance Manager - Skill Level 3: Duties include: Oversee the activity of the quality assurance deliverabl ...
-
Quality Assurance Manager
2 weeks ago
ENS Solutions, LLC St Louis, United StatesOversee the activity of the quality assurance deliverables · Develop, implement and maintain a system of quality and reliability testing · Provides development of project Software Quality Assurance Plan and the implementation of procedures that conforms to the requirements of t ...
-
Quality Assurance Manager
3 weeks ago
BuildSubmarines St Louis, United StatesQuality Assurance Manager · Key Role: · Oversee the activity of the quality assurance deliverables. Develop, implement, and maintain a system of quality and reliability testing. Provide development of project Sof tware Quality Assurance Plan and the implementation of procedures ...
-
Quality Assurance Manager
2 weeks ago
Vectrus St Louis, United StatesOverview · The Quality Assurance Manager position is responsible for the overall management and implementation of internal quality and serve as the central point of contact for quality matters. · Location: St. Louis, MO · Responsibilities · + · Oversee the activity of the qualit ...
Quality Assurance Manager - O'Fallon, United States - Anodyne Surgical
Description
Job Description
Job DescriptionOverview
Anodyne Surgical is seeking a skilled and detail-oriented Quality Assurance Manager to join our team. As a Quality Manager, you will play a crucial role in ensuring the quality and compliance of our medical devices. You will be responsible for conducting quality inspections, managing quality assurance processes, analyzing data, and implementing quality control measures.
About Anodyne Surgical
Anodyne Surgical is a privately held, mid-size manufacturing company specializing in producing disposable ophthalmic medical devices for eye surgery - typically cataract removal. We operate in our climate-controlled 13,000-square-foot factory/office building located near the intersection of I-64 and Highway K in O'Fallon, MO. Our high-volume products are modified, and custom cannulas are adapted for the unique needs of eye surgery. We offer our customers and distributors a wide range of custom products and rapid order fulfillment.
Duties
Leadership Skills
Salary and Benefits
Qualifications