At ACON labs, we are making a difference in medical care by offering medical devices for diagnosing a variety of conditions. In addition, we are able to streamline and reduce costs for the physician and/or patient directly. Come join us in developing the latest technologies that enhance human life and be a part of our growing, dynamic company.
We are seeking a Senior Quality Assurance Engineer to join our team. As a Senior Quality Engineer, you will manage and lead operations and continuous improvements of the company’s CAPAs, NCMR/Deviations and Supplier Management programs to ensure the best practices and compliance with federal and global regulatory requirements.
Essential Duties and Responsibilities (includes but not limited to):
CAPA Program
- Manage the company’s CAPA processes with focus on driving improvements in products and process performance.
- Coordinates and support activities for root cause investigations, and implementation of corrections and corrective actions, as well as evaluation of effectiveness of implemented changes.
- Facilitate cross functional team discussions in support of CAPA investigations and risk impact assessment report documents as per defined timelines.
- Monitor CAPA KPIs, perform analysis, and interpret trends for process/product quality improvements.
- Provide training and coaching to employees authoring, reviewing, and approving CAPAs.
- Provide subject matter expertise on CAPA activities to the overall site.
- Establish and maintain expert knowledge on quality system CAPA regulatory requirements in accordance with applicable FDA Regulations (21 CFR: Parts 820), and ICH Guidance, as well as other applicable regulatory requirements applicable to the organization.
Manufacturing Deviations, NCMRs, and Variances:
- Manage the process for issuing and evaluating Manufacturing Deviations and support resolution, as required.
- Manage the process for issuing and evaluating Non-Conformance records (NCMR’s) and support resolution of Quality issues.
- Manage the process for issuing and evaluating Variance reports for QMS processes and support resolution, as required.
Other:
- Participate in company’s Internal Audit program.
- Act as SME for CAPAs, Manufacturing Deviations, NCMRs, and Variances during Regulatory and Customers audits.
- Supports Management review by providing data and KPIs related to essential duties.
- Maintains Lot number database and provides part numbers and lot numbers as requested.
- Reviews/Scans upstream DHRs and creates COCs upon approval.
- Other duties may be assigned
Supervisory Responsibilities
May oversee and mentor junior staff
Education and/or Experience
Bachelor’s degree in life science or engineering, or equivalent focus of study from an accredited university or college with 5-8 plus years relevant experience or master’s degree with 3-5 plus years of relevant experience.
Required Knowledge, Skills and Abilities
- Proficient knowledge of Quality Engineering policies, principles and best practices including quality standards: ISO 13485, 21CFR Part 820, ISO 14971, and other appropriate industry standards.
- Strong team player.
- Must be well organized, detail-oriented and able to maintain precise records.
- Ability to multi-task, prioritize and manage time effectively, while maintaining quality.
- Must have strong oral and written communication skills and computer skills.
- Successful history of working independently with minimal supervision.
- Strong interpersonal skills with reputation for collaboration with colleagues
- Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project)
The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At ACON it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $81,000 -$95,000.
ACON offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and ACON may amend, terminate, or enhance the benefits provided, as it deems appropriate.